Class II
Terminated
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
This recall has been terminated (originally issued January 24, 2018).
- Company
- Unichem Pharmaceuticals Usa Inc
- Recall Initiated
- December 19, 2017
- Posted
- January 24, 2018
- Recall Number
- D-0228-2018
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 96,876 Bottles of 30s
- Firm Location
- Hasbrouck Heights, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Distribution
Product was distributed nationwide in the USA.
Lot / Code Info
Lot: ZDPH17040
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