D-1133-2019 Class II Terminated
FDA drug recall D-1133-2019 was initiated by Dr. Reddy's Laboratories, Inc. on April 11, 2019 and is designated Class II. Reason for recall: cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations. The recall status is terminated (terminated June 25, 2020). Affected quantity: 33,958 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2019
- Initiation Date
- April 11, 2019
- Termination Date
- June 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33,958 bottles
Product Description
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
Reason for Recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Distribution Pattern
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Code Information
Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020