D-0044-2024 Class III Terminated
FDA drug recall D-0044-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on October 4, 2023 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated February 2, 2024). Affected quantity: 144 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- October 25, 2023
- Initiation Date
- October 4, 2023
- Termination Date
- February 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 144 bottles
Product Description
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-737-86
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide in the USA.
Code Information
Lot #: HAD0360A, Exp. 12/2023