Teva Pharmaceuticals USA: Drug Recall

Recall #D-0232-2022 · 10/27/2021

Class II: Risk

Recall Details

Recall Number: D-0232-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Teva Pharmaceuticals USA
Status: Terminated
Date Initiated: 10/27/2021
Location: Parsippany, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 32316 bottles

Reason for Recall

Labelling: Incorrect Exp. Date

Product Description

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

Distribution Pattern

Distributed Nationwide in the USA

Other Recalls by Teva Pharmaceuticals USA

Class II: Risk 01/18/2022

Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
Class II: Risk 01/10/2022

Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class III: Low Risk 01/07/2022

Mislabeling
Class III: Low Risk 01/07/2022

Mislabeling
Class II: Risk 12/31/2021

Lack of Assurance of Sterility

View all recalls by Teva Pharmaceuticals USA →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.