buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed...
FDA Recall #D-0137-2024 — Class III — November 22, 2023
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
Recalling Firm
SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2016 Bottles
Distribution
Nationwide
Code Information
Lot HAD0630A, exp 1/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated