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

FDA recall notice · announced April 24, 2019 · Dr. Reddy's Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

Notes

Distribution: Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Lot/code information: Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
Quantity: 33,958 bottles
Status: Terminated
Products in this recall event:
- 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 (D-1133-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.