Class II · Moderate risk Ongoing
Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, Rx only, Distributed by: Bionpharma Inc., Princeton…
Reason Presence of Foreign Tablets/Capsules
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
What was recalled
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- NDC code
- 29300-140-01
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0228-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Divalproex recalls
See all
Class II · Moderate risk Terminated
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd…
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal…
Reason Failed dissolution specifications.
Class II · Moderate risk Terminated
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc…
Reason Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk Terminated
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's…
Reason cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
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