Class II · Moderate risk
Hydrocodone Bitartrate and Acetaminophen Tablets USP
Failed Tablet/Capsule Specifications; Product contains broken tablets.
Meprobamate
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
Affected NDC
0591-5238-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Watson Laboratories Inc
- NDC code
- 0591-5238-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-204-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Watson Laboratories Inc
All 2013 recalls
Class II · Moderate risk
Carisoprodol Tablets
Presence of Foreign Substance; metal particulates were visually observed in the tablets.
Class II · Moderate risk
Next Choice" One Dose Emergency Contraceptive
Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.
Class II · Moderate risk
Oxycodone and Acetaminophen Tablets
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.
Other impurity / degradation recalls from 2013
All impurity / degradation recalls
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class II · Moderate risk
Hydralazine HCL Tablets
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Class III · Low risk
Cetirizine Hydrochloride Syrup
Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone.
Class III · Low risk
Folic Acid Injection
Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point
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