Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

18 results found for foreign material Page 1 of 1
Zydus Pharmaceuticals (USA) Inc
Class II Completed
Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-021-01.
Reason: Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
D-0310-2025 April 16, 2025 Pennington, NJ
Lupin Pharmaceuticals Inc.
Class II Terminated
Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by...
Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
D-0496-2024 May 22, 2024 Baltimore, MD
Lupin Pharmaceuticals Inc.
Class II Terminated
Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by...
Reason: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
D-0497-2024 May 22, 2024 Baltimore, MD
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0074-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0078-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0079-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0075-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0077-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0076-2024 November 8, 2023 Saint Louis, MO
GlaxoSmithKline Consumer Healthcare Holdings LLC
Class II Completed
TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3
Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
D-0073-2024 November 8, 2023 Saint Louis, MO
Lupin Pharmaceuticals Inc.
Class II Terminated
Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-9...
Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
D-1536-2022 September 21, 2022 Baltimore, MD
RemedyRepack Inc.
Class II Terminated
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00
Reason: Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
D-1538-2022 September 21, 2022 Indiana, PA
B & B Pharmaceuticals, Inc.
Class II Terminated
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 8...
Reason: cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
D-1244-2020 April 22, 2020 Englewood, CO
SCA Pharmaceuticals, LLC
Class II Terminated
Lidocaine HCl 2% 5 mL, Syringe, Rx Only, SCA Pharmaceuticals 755 Rainbow Road Windsor, CT 08695 NDC 70004-0723-09
Reason: Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
D-0620-2020 December 18, 2019 Windsor, CT
AuroMedics Pharma LLC
Class II Terminated
Lidocaine HCl Injection, USP, 2% 100 mg/5 mL (20 mg/mL), Preservative-Free, packaged in 10 x 5 mL Single Dose Vials per carton, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown...
Reason: Presence of Foreign Substance: Foreign material found inside the vial.
D-0573-2020 December 4, 2019 East Windsor, NJ
Morton Grove Pharmaceuticals, Inc.
Class II Terminated
Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, Manufactured By: Cipla Ltd. at Medispray Laboratories Pvt. Ltd., Kund...
Reason: Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
D-1125-2017 September 6, 2017 Morton Grove, IL
Mckesson Packaging Services
Class II Completed
Aspirin Chewable Tablets, 81 mg, (NSAID*), packaged in UD 750 Tablets (25 x 30) tablets in blisters per carton, Dist. By: McKesson Packaging Services, a business unit of McKesson Corporation, 7101 Wed...
Reason: Presence of Foreign Substance: foreign material found in the bulk inventory.
D-0513-2017 March 15, 2017 Concord, NC
Glenmark Generics Inc., USA
Class II Terminated
Ranitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manuf...
Reason: Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bot...
D-1229-2014 April 16, 2014 Mahwah, NJ