Reported Apr 24, 2019 · Terminated
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle…
Dr. Reddy's Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- 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
- ByDr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
- Lot codes and dates
Lot #: a) C802629Exp. 03/2020C805680Exp. 07/2020C808821Exp. 10/2020b) C806561Exp. 10/2020
- Amount recalled
- 33,958 bottles
Why it was recalled
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
This product could cause temporary or reversible health problems — stop using it.
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