February 2015 FDA Recall Drug by Tarmac Products, Inc.
D-0419-2015 - Microbial Contamination of Non-Sterile Products

This Class II drug recall was voluntarily initiated by Tarmac Products, Inc. on February 6, 2015 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-0419-2015

Reason for Recall
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Initiated
02-06-2015
Reported
03-25-2015
Quantity
78,591 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
70577
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.
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.
12-30-2016
Product Description About Product Description
Full technical description of the product.
Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.

Batch or Lot Expiration Information

Lot# : 7599 (Refer to lot 13L0009), 7600 (Refer to lot 13K0014), 7622 (Refer to lot 13L0008), 7623 (Refer to lot 13K0015), Exp 10/15