May 2023 FDA Recall Bupropion Hydrochloride by Sun Pharmaceutical Industries Inc
D-0761-2023 - Failed Dissolution Specifications; during stability testing
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on May 9, 2023 for the product Bupropion Hydrochloride. The FDA reported the reason for recall as failed dissolution specifications; during stability testing. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0761-2023
Failed Dissolution Specifications; during stability testing
05-09-2023
05-31-2023
5,344 Bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A
02-27-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lots: HAC2240A, Exp 05/2023; HAC3162A, Exp 07/2023
