Class IIAmoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx only, manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-2277-7.2025-11-12
Subpotent drug; Clavulanate Potassium component
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIAmoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, Manufactured in Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-2272-342024-06-26
Subpotent Drug
Recalling firm: Teva Pharmaceuticals USA, Inc
Class IIAMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-202024-01-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm: CARDINAL HEALTHCARE
Class IIAMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-732024-01-03
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Recalling firm: CARDINAL HEALTHCARE
Class IIAmoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-012022-06-15
cGMP deviations: Temperature abuse
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Class IIAmoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bottles, Distributed by: Aurobindo Pharma USA. Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India; NDC 65862-503-202020-02-19
Presence of Foreign Substance: Customer complaint of a foreign substance identified as nylon cable tie
Recalling firm: AuroMedics Pharma LLC
Class IIAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.2019-04-24
Subpotent Product: assay results for Amoxicillin were below the specification limits.
Recalling firm: Teva Pharmaceuticals USA
Class IIAmoxicillin 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., Kundaim Goa, India; Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054, NDC 60432-065-00.2017-09-06
Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove was discovered in product.
Recalling firm: Morton Grove Pharmaceuticals, Inc.
Class IIIAmoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-202017-06-07
Subpotent Drug; Clavulanic Acid
Recalling firm: Sandoz Inc
Class IIAmoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-732017-02-01
Subpotency: due to a low, out of specification test result for assay during stability testing.
Recalling firm: Teva Pharmaceuticals USA
Class IIIAmoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-012016-11-30
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Recalling firm: West-Ward Pharmaceuticals Corp.
Class IIIAmoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,2016-09-28
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Recalling firm: West-Ward Pharmaceuticals Corp.
Class IIAmoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-762016-08-31
Superpotent drug: Out of specification test result for assay during stability testing.
Recalling firm: Teva North America
Class IIAmoxicillin Trihydrate 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
Stability Data Does Not Support Expiry: All lots of all products repackaged and distributed between 01/05/12 through 02/12/15 are being recalled because they were repackaged withou
Recalling firm: Attix Pharmaceuticals
Class IItriple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxicillin Capsules USP manufactured in Canada, for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC# 0093-8055-782014-08-06
Failed Impurities/Degradation Specifications: This recall is due to out of specification for impurities test results obtained during stability testing for Lansoprazole.
Recalling firm: Teva Pharmaceuticals USA
Class IIIAmoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.2013-07-24
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
Recalling firm: Teva Pharmaceuticals USA, Inc.
Class IIIAmoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL)2013-06-19
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
Recalling firm: Teva Pharmaceuticals USA, Inc.
Class IIAmoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.2013-05-01
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Recalling firm: Sandoz Incorporated
Class IIAmoxicillin for Oral Suspension, 125mg/5mL, a) 80 mL (NDC 43598-222-80); b) 100mL, (NDC 43598-222-52); c)150 mL (NDC 43598-222-53) bottles, Rx only, Dist. By: Dr. REDDY'S Laboratories, Inc., Bridgewater, NJ 088072013-04-10
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Recalling firm: Dr Reddys Laboratories Tennessee LLC