Class IIOmeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands, NDC 82009-022-10. NDC 82009-022-102025-07-23
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIOmeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.2024-03-06
Subpotent Drug: Out of specification for assay
Recalling firm: Bausch Health Companies, Inc.
Class IIOmeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC 70000-0232-12021-10-27
CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Class IIPrilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland2021-06-02
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm: Cardinal Health Inc.
Class IIOmeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-102021-03-31
Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer
Recalling firm: Golden State Medical Supply Inc.
Class IIOmeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-102021-03-24
Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.
Recalling firm: Breckenridge Pharmaceutical, Inc
Class IIOmeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-072019-02-06
Lack of Processing Controls.
Recalling firm: Duren Health Mart Pharmacy
Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-032016-11-23
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg
Recalling firm: CutisPharma, Inc.
Class IIIFIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-052016-11-23
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg
Recalling firm: CutisPharma, Inc.
Class IIOmeprazole active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada2015-04-29
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with
Recalling firm: Attix Pharmaceuticals
Class IIOmeprazole Sodium active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada2015-04-29
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with
Recalling firm: Attix Pharmaceuticals
Class IIOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 115237265032014-01-22
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD70655_8, EXP:
Recalling firm: Aidapak Services, LLC
Class IIOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 115237265032014-01-22
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC 00536323307, Pedigree: AD49399
Recalling firm: Aidapak Services, LLC
Class IIOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 115237265032014-01-22
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: W003788,
Recalling firm: Aidapak Services, LLC
Class IIOMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 115237265032014-01-22
Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC 63824073116, Pedigree: A
Recalling firm: Aidapak Services, LLC
Class IIOmeprazole Delayed-Release Capsules, USP, 20 mg, Rx Only, 1000 Capsules per bottle, Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA, NDC: 62175-118-432013-11-27
Failed Tablet/Capsule Specification: some capsules over time do not meet or are suspected to not meet the specification for acid resistance.
Recalling firm: Kremers Urban Pharmaceuticals, Inc.