Why it was recalled
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Product description
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
Lot numbers, UPCs & expiration codes
Lot: ZDPH17040
Where it was sold
Product was distributed nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0228-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 19, 2017
- FDA report date
- Jan 24, 2018
- Quantity
- 96,876 Bottles of 30s
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
Original FDA data
Every field from FDA enforcement report D-0228-2018, exactly as published.
Show all FDA fields
- City
- Hasbrouck Heights
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78786
- Address
- 777 Terrace Ave
- Address (line 2)
- Suite 102
- Code information
- Lot: ZDPH17040
- Postal code
- 07604-3102
- Report date
- Jan 24, 2018
- Product type
- Drugs
- Recall number
- D-0228-2018
- Classification
- Class II
- Recalling firm
- Unichem Pharmaceuticals Usa Inc
- Product quantity
- 96,876 Bottles of 30s
- Termination date
- Sep 12, 2018
- Reason for recall
- Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed nationwide in the USA.
- Recall initiation date
- Dec 19, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 17, 2018