August 2021 FDA Recall Carvedilol by Zydus Pharmaceuticals (usa) Inc (D-0753-2021 - Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle)
This Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on August 13, 2021 for the product Carvedilol. The FDA reported the reason for recall as presence of foreign tablets/capsules; report of two paroxetine tablets were found in the bottle. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0753-2021
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
08-13-2021
08-25-2021
2880 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.
Zydus Pharmaceuticals (USA) 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 US
04-03-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Carvedilol Tablets, USP 25 mg, 500 Tablets bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0853, NDC 68382-095-05
Batch or Lot Expiration Information
Lot# Z006279, exp 12/31/2022
