FDA recall record

Cartia XT recall — FDA D-0232-2022

Labelling: Incorrect Exp. Date

Class IIclassification
D-0232-2022official record ID
Nov 24, 2021report date

Recall record at a glance

Official recordD-0232-2022
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmTeva Pharmaceuticals USA
Report dateNov 24, 2021
Recall initiation dateOct 27, 2021
Quantity32316 bottles
LocationParsippany, NJ, United States

Official 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

Why the product was recalled

Labelling: Incorrect Exp. Date

Distribution information

Distributed Nationwide in the USA

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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