October 2021 FDA Recall Cartia by Teva Pharmaceuticals Usa
D-0232-2022 - Labelling
This Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa on October 27, 2021 for the product Cartia. The FDA reported the reason for recall as labelling. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0232-2022
Labelling: Incorrect Exp. Date
10-27-2021
11-24-2021
32316 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.
Teva Pharmaceuticals USA
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.
Distributed Nationwide in the USA
12-21-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054; (b) Manufactured By: Actavis Laboratories FL. Inc, Fort Lauderdale FL. 33314 USA, Distributed by Avista Pharma Inc. Parsippany, NJ 07054 USA. NDC 62037-597-90
Batch or Lot Expiration Information
Lot# 100023805, Exp. Date 05/2023
