Recalls / Class II
Class IID-0228-2018
Product
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
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDCs
- 29300-138, 29300-139, 29300-140
- FDA application
- ANDA079163
- Affected lot / code info
- Lot: ZDPH17040
Why it was recalled
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Recalling firm
- Firm
- Unichem Pharmaceuticals Usa Inc
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 777 Terrace Ave, Suite 102, Hasbrouck Heights, New Jersey 07604-3102
Distribution
- Quantity
- 96,876 Bottles of 30s
- Distribution pattern
- Product was distributed nationwide in the USA.
Timeline
- Recall initiated
- 2017-12-19
- FDA classified
- 2018-01-17
- Posted by FDA
- 2018-01-24
- Terminated
- 2018-09-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0228-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.