September 2014 FDA Recall Drug by American Family Pharmacy, Llc
D-0040-2015 - Subpotent Drug

This Class II drug recall was voluntarily initiated by American Family Pharmacy, Llc on September 15, 2014 for the product Drug. The FDA reported the reason for recall as subpotent drug. The product was distributed in VA, WA, and CA. and the recall is currently terminated.

Recall Number: D-0040-2015

Reason for Recall
Subpotent Drug: Product failed to meet USP Specifications on assay, content uniformity, and dissolution.
Initiated
09-15-2014
Reported
10-29-2014
Quantity
4,207,200 tablets

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69248
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.
American Family Pharmacy, LLC
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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
VA, WA, and CA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-25-2015
Product Description About Product Description
Full technical description of the product.
Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.

Batch or Lot Expiration Information

Lot# 12084; Exp. 05/16