FDA-Drug2022-08-03Class II
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.
Hazard
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Sold states
Nationwide in the USA
Affected count
9552 bottles
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1291-2022More SUN PHARMACEUTICAL INDUSTRIES INC recalls
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