Home / Recalls / SUN PHARMACEUTICAL INDUSTRIES INC / D-1291-2022

D-1291-2022 Class II Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Recall Details

Product Type
Drugs
Report Date
August 3, 2022
Initiation Date
June 27, 2022
Termination Date
May 31, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9552 bottles

Product Description

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 for Recall

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

Distribution Pattern

Nationwide in the USA

Code Information

Lot: HAC1312A, EXP. 05/2024

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