D-1291-2022 Class II Terminated
FDA drug recall D-1291-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Jun 27, 2022 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test. The recall status is terminated (terminated May 31, 2023). Affected quantity: 9552 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 3, 2022
- Initiation Date
- Jun 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1291-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026