Class II
Terminated
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
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- April 11, 2019
- Posted
- April 24, 2019
- Recall Number
- D-1133-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 33,958 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Distribution
Product was distributed to major distributors and retailers who may have further distribute the product throughout the United States.
Lot / Code Info
Lot #: a) C802629, Exp. 03/2020; C805680, Exp. 07/2020, C808821,Exp. 10/2020; b) C806561, Exp. 10/2020
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