Drug recall D-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
Reason for recall
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
Lots and codes
Lot #: C802676, Exp 03/20
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 10,656 bottles
- Distribution
- U.S.A. Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 31, 2019
- Terminated
- February 14, 2023
Related products
- Divalproex Sodium – drug information
- NDC 55111-533 Divalproex Sodium · Divalproex Sodium 250 mg/1 · Dr. Reddy's Laboratories Ltd