Class IIRanitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-302020-10-14
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Direct Rx
Class IIRanitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 305342020-10-14
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Direct Rx
Class IIRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-272020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-712020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-652020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-012020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-622020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-062020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-752020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-582020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-822020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-022020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-092020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-092020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-472020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-012020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-512020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIMaximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-752020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIRegular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12;2020-03-25
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Recalling firm: Perrigo Company PLC
Class IIRanitidine Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 610802020-03-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API.
Recalling firm: Precision Dose Inc.
Class IIRanitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-112020-03-18
CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Recalling firm: American Health Packaging
Class IIRanitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram2020-02-12
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Spectrum Laboratory Products
Class IIranitidine hydrochloride, USP ,150 mg tablets a) 14-count bottles ( NDC 43063-844-14); b) 30-count bottles (NDC 43063-844-30); c) 60 -count bottles( NDC 43063-844-60); d) 90-count bottles (NDC 43063-844-90); e) 100-count bottles ( NDC 43063-844-01), Rx Only, Distributed by: PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 731272020-02-12
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Recalling firm: PD-Rx Pharmaceuticals, Inc.
Class IIRanitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.2020-01-29
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Denton Pharma, Inc.
Class IIRanitidine, 150 mg Tablets, a) 7 count, b) 14 count, c) 20 count, d) 30 count, e) 60 count; Rx, Only, H.J. Harkins Company, Inc. dba Pharma Pac Grover Beach, CA 93433 NDC #s: 52959-0502-07, 52959-0502-14, 52959-0502-20, 52959-0502-30 and 52959-0502-602020-01-29
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: H J Harkins Company Inc dba Pharma Pac
Class IIRanitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 121312020-01-29
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Denton Pharma, Inc.
Class IIPreferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)2020-01-29
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Preferred Pharmaceuticals, Inc
Class IIPreferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)2020-01-29
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Preferred Pharmaceuticals, Inc
Class IIGlenmark Ranitidine Tablets USP 300 mg Rx Only 250 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-202020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIGlenmark Ranitidine Tablets USP 300 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-012020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIRanitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.2020-01-15
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Appco Pharma LLC
Class IIGlenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-602020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIGlenmark Ranitidine Tablets USP 150 mg Rx Only 500 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-052020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIRanitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.2020-01-15
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: AAA Pharmaceutical, Inc.
Class IIRanitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.2020-01-15
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: AAA Pharmaceutical, Inc.
Class IIGlenmark Ranitidine Tablets USP 150 mg Rx Only 100 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-012020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIGlenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-302020-01-15
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Class IIRanitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.2020-01-15
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Appco Pharma LLC
Class IIRANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-322020-01-08
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Granules India Limited
Class IIRanitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)2020-01-08
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: American Health Packaging
Class IIRanitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals2019-12-18
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Preferred Pharmaceuticals, Inc
Class IIRanitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Amneal Pharmaceuticals, Inc.
Class IIRanitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Amneal Pharmaceuticals, Inc.
Class IIRanitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Amneal Pharmaceuticals, Inc.
Class IIRanitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Amneal Pharmaceuticals, Inc.
Class IIRanitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90.2019-12-18
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: Amneal Pharmaceuticals, Inc.
Class IIRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-742019-12-04
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm: AuroMedics Pharma LLC
Class IIAVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 a) 1000 tablets NDC 42291-724-10; b) 180 tablets NDC 42291-724-18; c) 60 tablets NDC 42291-724-602019-12-04
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: AVKARE Inc.
Class IIAVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-302019-12-04
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm: AVKARE Inc.
Class IIAurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-302019-12-04
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm: AuroMedics Pharma LLC
Class IIAurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-602019-12-04
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm: AuroMedics Pharma LLC
Class IIAurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-052019-12-04
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm: AuroMedics Pharma LLC
Class IIDG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-792019-12-04
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
Recalling firm: AuroMedics Pharma LLC
Class IINovitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-402019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Novitium Pharma LLC
Class IIEquate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-002019-11-20
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Recalling firm: Apotex Inc.
Class IINovitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-202019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Novitium Pharma LLC
Class IIEquate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 727162019-11-20
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Recalling firm: Apotex Inc.
Class IINovitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-102019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Novitium Pharma LLC
Class IIGSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.2019-11-20
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm: Golden State Medical Supply Inc.