Reported Aug 3, 2022 · Terminated
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical…
Sun Pharmaceutical Industries 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: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured bySun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88
- Lot codes and dates
- Lot
HAC1312AEXP. 05/2024
- Lot
- Amount recalled
- 9552 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
This product could cause temporary or reversible health problems — stop using it.
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