May 2023 FDA Recall Buprenorphine by Sun Pharmaceutical Industries Inc
D-0869-2023 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on May 3, 2023 for the product Buprenorphine. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0869-2023
CGMP Deviations
05-03-2023
06-14-2023
12,336 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.
Product was distributed to 19 distributors nationwide.
01-09-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactured by: Sun Pharma, NDC 62756-460-83.
Batch or Lot Expiration Information
Lot# : DND1515A, Exp 08/24
