SUN PHARMACEUTICAL INDUSTRIES INC recalls Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industrie
Recalled August 3, 2022 · FDA recall D-1291-2022 · SUN PHARMACEUTICAL INDUSTRIES
Hazard
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. · FDA Class II
Units
9552 bottles
Sold at
Nationwide in the USA
Description
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Product
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
Manufacturer(s)
SUN PHARMACEUTICAL INDUSTRIES INC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →