November 2018 FDA Recall Drug by L. Perrigo Company
D-0266-2019 - Presence of foreign substance

This Class II drug recall was voluntarily initiated by L. Perrigo Company on November 6, 2018 for the product Drug. The FDA reported the reason for recall as presence of foreign substance. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0266-2019

Reason for Recall
Presence of foreign substance: Product found to contain metal particles.
Initiated
11-06-2018
Reported
11-28-2018
Quantity
70,170 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
81473
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
L. Perrigo Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-28-2020
Product Description About Product Description
Full technical description of the 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]

Batch or Lot Expiration Information

Lot# Lots: PA17-412, PA17-077, PA17-196,PA17-127, PA17-150, Exp 11/18