D-0507-2019 Class II Terminated
FDA drug recall D-0507-2019 was initiated by Dr. Reddy's Laboratories, Inc. on January 31, 2019 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Out of specification results observed for high dissolution. The recall status is terminated (terminated February 14, 2023). Affected quantity: 10,656 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 27, 2019
- Initiation Date
- January 31, 2019
- Termination Date
- February 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,656 bottles
Product Description
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.
Distribution Pattern
U.S.A. Nationwide
Code Information
Lot #: C802676, Exp 03/20