Recalls / Class II
Class IID-0507-2019
Product
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
- Brand name
- Divalproex Sodium
- Generic name
- Divalproex Sodium
- Active ingredient
- Divalproex Sodium
- Route
- Oral
- NDC
- 55111-533
- FDA application
- ANDA090161
- Affected lot / code info
- Lot #: C802676, Exp 03/20
Why it was recalled
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 10,656 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2019-01-31
- FDA classified
- 2019-02-15
- Posted by FDA
- 2019-02-27
- Terminated
- 2023-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0507-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.