Recall: D-1291-2022

Class II - Potentially Harmful

Class IIClassification

2022-06-27Initiated

TerminatedStatus

SUN PHARMACEUTICAL INDUSTRIES Firm

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.

Reason

Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.