Watson Laboratories Inc Recalls

All product recalls associated with Watson Laboratories Inc.

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Recall Summary

Total Recalls

24

Past Year

0

Class I (Serious)

1

Most Recent

Jan 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 24 recalls

Hydrocodone Acetaminophen Tablets (Watson) – broken tablets (2014)

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Class IIModerate

FDAJan 15, 2014AZ, CA, CT +8 more• Watson Laboratories Inc

Carisoprodol Tablets (Watson Laboratories) – Metal Particulates (2013)

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

Class IIModerate

FDADec 23, 2013Nationwide• Watson Laboratories Inc

Diclofenac Sodium Tablets (Watson) – Tablet Split Issue (2013)

Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Class II

Moderate

FDADec 20, 2013Nationwide• Watson Laboratories, Inc.-(Actavis) - Florida

Next Choice Emergency Contraceptive (Watson) – Tablet Breakage (2013)

Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Class IIModerate

FDASep 23, 2013Nationwide• Watson Laboratories Inc

Oxycodone Acetaminophen Tablets (Watson) – Foreign Tablets (2013)

Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A.

Class IIModerate

FDASep 13, 2013Nationwide• Watson Laboratories Inc

Hydrocodone Acetaminophen Tablets (Watson) – Defective Container (2013)

Defective Container: Defective bottles may not have tamper evident seals properly seated, and therefore it may be difficult to determine if the product had been opened or tampered with.

Class IIILow

FDAAug 30, 2013Nationwide• Watson Laboratories Inc

Oxycodone/Acetaminophen Capsules (Watson) – Subpotent Drug (2013)

Subpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.

Class IIILow

FDAJul 19, 2013Nationwide• Watson Laboratories Inc

Diclofenac Sodium Misoprostol Tablets (Watson) – Broken Tablets (2013)

Failed Tablet/Capsule Specifications: Broken tablets

Class IIModerate

FDAMar 22, 2013Nationwide• Watson Laboratories, Inc.-(Actavis) - Florida

ZARAH Tablets (Watson) – Tablet Breakage (2013)

Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .

Class IIModerate

FDAFeb 13, 2013Nationwide• Watson Laboratories Inc

Meprobamate 400mg Tablets (Watson) – Impurity Specification (2013)

Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .

Class IIModerate

FDAFeb 8, 2013Nationwide• Watson Laboratories Inc

Meprobamate 200mg Tablets (Watson) – Impurity Specification (2013)

Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .

Class IIModerate

FDAFeb 8, 2013Nationwide• Watson Laboratories Inc

Caziant Tablets (Watson Laboratories) – Impurity Concern (2012)

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

Class IIILow

FDADec 13, 2012Nationwide• Watson Laboratories Inc