D-0761-2023 Class II Terminated
FDA drug recall D-0761-2023 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on May 9, 2023 and is designated Class II. Reason for recall: Failed Dissolution Specifications; during stability testing The recall status is terminated (terminated February 27, 2024). Affected quantity: 5,344 Bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 31, 2023
- Initiation Date
- May 9, 2023
- Termination Date
- February 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,344 Bottles
Product Description
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86
Reason for Recall
Failed Dissolution Specifications; during stability testing
Distribution Pattern
Nationwide in the U.S.A
Code Information
Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023