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Teva Pharmaceuticals USA

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
201812
20196
202022
202153
20227
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FDA Recall Terminated Historical recordClass III

Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56

by Teva Pharmaceuticals USA

Reason
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Published
February 21, 2018
Distribution
Distributed throughout the United States

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FDA Recall Terminated Historical recordClass III

Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Published
February 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Published
February 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Published
February 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Published
February 14, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Published
January 17, 2018
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
Published
December 27, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufactured In Canada By: Teva Canada Limited, Toronto, Canada M1B 2K9; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454; NDC 0093-4125-73.

by Teva Pharmaceuticals USA

Reason
Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
Published
December 20, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem Israel, Manufactured For: TEVA PHARMACEUTICALS USA, North Wales, PA, NDC 00093-7772-05

by Teva Pharmaceuticals USA

Reason
Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Published
December 6, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Dutasteride and Tamsulosin HCl Capsules, 0.5 mg/ 0.4 mg, packaged in a) 30-count bottle (NDC 0591-3771-30), b) 90-count bottle (NDC 0591-3771-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA.

by Teva Pharmaceuticals USA

Reason
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Published
November 8, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass III

Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: Low out of specification results for dissolution.
Published
November 1, 2017
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

Acarbose Tablets, 25 mg, 100-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 16252-523-01.

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: An incorrect expiration date of July 2018 is printed on the product labeling rather than the correct expiration date of July 2017.
Published
October 4, 2017
Distribution
Nationwide

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This page lists recalls that name Teva Pharmaceuticals USA as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.