Unichem Recalls Divalproex Sodium Tablets Due to Metronidazole Contamination
Unichem Pharmaceuticals is recalling Divalproex Sodium tablets because metronidazole powder was found in one bottle. The product was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves cross-contamination with another drug (metronidazole), which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Unichem Pharmaceuticals (USA), Inc. is recalling Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottles. The recall was initiated because metronidazole powder was found in one bottle of the product. The affected lot is ZDPH17040, and the product was distributed nationwide in the USA.
The product is a prescription-only medication manufactured by Unichem Laboratories Ltd. in India and marketed by Unichem Pharmaceuticals (USA), Inc. in Hasbrouck Heights, NJ. The specific NDC for the recalled item is 29300-140-01.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps. The recall is classified as Class II by the FDA.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Unichem Pharmaceuticals Usa Inc
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: ZDPH17040
UPCs (1)
- 0329300140019
Distribution
Distributed nationwide across the United States.
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