Recalls / Class II
Class IID-1133-2019
Product
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
- Affected lot / code info
- Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
Why it was recalled
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 33,958 bottles
- Distribution pattern
- Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Timeline
- Recall initiated
- 2019-04-11
- FDA classified
- 2019-04-15
- Posted by FDA
- 2019-04-24
- Terminated
- 2020-06-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1133-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.