Divalproex Sodium Delayed-Release Tablets…

Date

Aug. 3, 2022

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Sun Pharmaceutical Industries Inc

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 pattern

Nationwide in the USA

Quantity

9552 bottles

Codes and lots

Lot: HAC1312A, EXP. 05/2024

Recall started

June 27, 2022

Recall number

D-1291-2022

What should I do? Medicine recall: what to do

Source: FDA · Drug enforcement report, recall number D-1291-2022. The agency record governs; check it and the company before acting.