Recalls / Class II
Class IID-1291-2022
Product
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDCs
- 62756-796, 62756-797, 62756-798
- FDA application
- ANDA078597
- Affected lot / code info
- Lot: HAC1312A, EXP. 05/2024
Why it was recalled
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 9552 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-06-27
- FDA classified
- 2022-07-26
- Posted by FDA
- 2022-08-03
- Terminated
- 2023-05-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1291-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.