Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx Only, 90 capsules, labelled as (a) Manufac
Summary
The FDA issued a Class II for Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP) 120 mg, Rx On by Teva Pharmaceuticals USA. Reason: Labelling: Incorrect Exp. Date.
Details
Source
Drug Recall
External ID
D-0232-2022
Action Date
2021-11-24
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # 100023805, Exp. Date 05/2023
Quantity Affected: 32316 bottles
Reason for Recall
Labelling: Incorrect Exp. Date
Distribution
Distributed Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-27
Company
Parsippany, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 178 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Teva Pharmaceuticals USA) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Teva Pharmaceuticals USA have FDA actions?
Teva Pharmaceuticals USA has 38 FDA actions in our database, including 38 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0232-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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