Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-050-442024-05-22
Presence of foreign substance: plastic-like substance.
Recalling firm: MACLEODS PHARMA USA, INC
Class IILosartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-082023-07-12
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Recalling firm: Strides Pharma Inc.
Class IILosartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 82022-07-06
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 52022-07-06
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 12022-07-06
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Class IILosartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-07-06
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-934-05 1000 film coated tablets NDC 64380-934-082022-06-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
Class IILosartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-902022-06-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Direct Rx
Class IILosartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-935-05 1000 film coated tablets NDC 64380-935-082022-06-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
Class IILosartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No., 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816. 90 film coated tablets NDC 64380-933-05 1000 film coated tablets NDC 64380-933-082022-06-08
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Strides Pharma Inc.
Class IILosartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 085402022-06-01
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm: Direct Rx
Class IILosartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 085402022-06-01
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Recalling firm: Direct Rx
Class IILosartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 085362022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.2022-05-11
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Recalling firm: Lupin Pharmaceuticals Inc.
Class IILosartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.2022-05-04
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Recalling firm: RemedyRepack Inc.
Class IILosartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-902021-05-05
CGMP deviation: Product found to contain trace amounts of NMBA
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Class IILosartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-302020-10-14
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufactu
Recalling firm: Direct Rx
Class IILosartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India2020-09-02
Failed Tablet/Capsule Specification; complaint of bulging tablet
Recalling firm: Hetero Labs Limited (Unit V)
Class IILosartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA2020-04-22
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 088162020-04-15
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Recalling firm: Avet Pharmaceuticals, Inc.
Class IILOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-002020-04-15
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Teva Pharmaceuticals USA
Class IILOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-002020-04-15
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Teva Pharmaceuticals USA
Class IILosartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 count (NDC 23155-645-09) and c) 1000 count (NDC 23155-645-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India, Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816 NDC 23155-645-092020-04-15
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level
Recalling firm: Avet Pharmaceuticals, Inc.
Class IILOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-002020-04-15
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Teva Pharmaceuticals USA
Class IILosartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-902019-10-09
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts
Recalling firm: Torrent Pharma Inc.
Class IILosartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-902019-10-09
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts
Recalling firm: Torrent Pharma Inc.
Class IILosartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-102019-10-09
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts
Recalling firm: Torrent Pharma Inc.
Class IILOSARTAN POTASSIUM 50 mg TABLET BULK 90 count bottles and 1000 count bottles, NDC 00591-3746-002019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Teva Pharmaceuticals USA
Class IILosartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.2019-07-17
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: MAJOR PHARMACEUTICALS
Class IILosartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-442019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Macleods Pharma Usa Inc
Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-050-102019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Macleods Pharma Usa Inc
Class IILOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-002019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Teva Pharmaceuticals USA
Class IILosartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-102019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-302019-07-17
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 25 mg 30 count bottle NDC 60429-316-30 Rx only GSMS Incorporated2019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-092019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Heritage Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx only GSMS Incorporated2019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-092019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Heritage Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx only GSMS Incorporated2019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-644-092019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Heritage Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets USP 100 mg 90 count bottle NDC 60429-318-90 Rx only GSMS Incorporated2019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-646-102019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Heritage Pharmaceuticals, Inc.
Class IILosartan Potassium Tablets USP 25 mg 90 count bottle NDC 60429-316-90 Rx only GSMS Incorporated2019-05-29
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Golden State Medical Supply Inc.
Class IILosartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ2019-05-22
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufa
Recalling firm: Preferred Pharmaceuticals, Inc
Class IILosartan Potassium Tablets, USP, 100 mg, a) 90-count (NDC: 13668-115-90), b)1000-count (NDC: 13668-115-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India2019-05-08
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Recalling firm: Torrent Pharma Inc.
Class IILosartan Potassium Tablets, USP, 25 mg, a) 90-count (NDC: 13668-113-90), b)1000-count (NDC: 13668-113-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India2019-05-08
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Recalling firm: Torrent Pharma Inc.
Class IILosartan Potassium and Hydrochlorothiazide Tablets, USP, 50mg/12.5mg, a) 30-count (NDC: 13668-116-30), b) 90-count (NDC: 13668-116-90), c) 1000-count (NDC: 13668-116-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India2019-05-08
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Recalling firm: Torrent Pharma Inc.
Class IILosartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 384782019-05-08
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts
Recalling firm: AVKARE Inc.