February 2017 FDA Recall Drug by Allegiant Health
D-0500-2017 - cGMP deviations - presence of rubber particles found loose in the bulk product.

This Class II drug recall was voluntarily initiated by Allegiant Health on February 16, 2017 for the product Drug. The FDA reported the reason for recall as cgmp deviations - presence of rubber particles found loose in the bulk product.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0500-2017

Reason for Recall
cGMP deviations - presence of rubber particles found loose in the bulk product.
Initiated
02-16-2017
Reported
03-08-2017
Quantity
70,176 bottles; 9,000,000 tablets (bulk)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76495
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.
Allegiant Health
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.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2018
Product Description About Product Description
Full technical description of the product.
HealthA2Z CHEWABLE Aspirin (NSAID) 81 mg, Orange Flavor, 36 Chewable Tablets, a) packaged in 36-count bottle [UPC Code 369168288362 (FP0545)], b) bulk product (6K28817), OTC, Manufactured by: Allegiant Health Deer Park, NY 11729

Batch or Lot Expiration Information

Lot# 6K28817, Exp 10/19 (Packaged in bottle), 10/17 (Bulk)