FDA Drug Recalls

Recalls / Class II

Class IID-0266-2019

Product

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]

Affected lot / code info
Lots: PA17-412, PA17-077, PA17-196,PA17-127, PA17-150, Exp 11/18

Why it was recalled

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

Recalling firm

Firm
L. Perrigo Company
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
515 Eastern Ave, N/A, Allegan, Michigan 49010-9070

Distribution

Quantity
70,170 bottles
Distribution pattern
Nationwide USA

Timeline

Recall initiated
2018-11-06
FDA classified
2018-11-20
Posted by FDA
2018-11-28
Terminated
2020-09-28
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0266-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls