D-0137-2024 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 13, 2023
- Initiation Date
- November 22, 2023
- Termination Date
- June 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2016 Bottles
Product Description
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India NDC 47335-738-86
Reason for Recall
Failed Dissolution Specifications
Distribution Pattern
Nationwide
Code Information
Lot HAD0630A, exp 1/2024