FDA recall record

L. Perrigo Company Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count recall — FDA D-0266-2019

Presence of foreign substance: Product found to contain metal particles.

Class IIclassification
D-0266-2019official record ID
Nov 28, 2018report date

Recall record at a glance

Official recordD-0266-2019
CategoryDrug Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmL. Perrigo Company
Report dateNov 28, 2018
Recall initiation dateNov 6, 2018
Quantity70,170 bottles
LocationAllegan, MI, United States

Official product description

Antacid Tablets, Calcium Carbonate chewable tablets, 750mg, 60-count bottle, OTC, [Healthy Accents brand NDC: 55316-014-72, Distributed by DZA Brands, LLC, Salisbury, NC 28147, Scarborough, ME 04074], [HealthMart Pharmacy brand NDC: 62011-0295-1, Distributed by McKessen, One Post Street, San Francisco, CA 94104], [DG health brand NDC: 55910-717-72, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072]

Why the product was recalled

Presence of foreign substance: Product found to contain metal particles.

Distribution information

Nationwide 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

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