March 2013 FDA Recall Drug by Tarmac Products, Inc. D.b.a. Axara Pharmaceuticals
D-311-2013 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Tarmac Products, Inc. D.b.a. Axara Pharmaceuticals on March 16, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-311-2013

Reason for Recall
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Initiated
03-16-2013
Reported
05-08-2013
Quantity
13,369 bottles (12oz), 2607 bottles (26oz)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64963
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.
Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
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.
06-25-2013
Product Description About Product Description
Full technical description of the product.
"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.

Batch or Lot Expiration Information

Lot# Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)