D-311-2013 Class II Terminated

Recalled by Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals — Miami Gardens, FL

Recall Details

Product Type
Drugs
Report Date
May 8, 2013
Initiation Date
March 16, 2013
Termination Date
June 25, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13,369 bottles (12oz), 2607 bottles (26oz)

Product Description

"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.

Reason for Recall

Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.

Distribution Pattern

Nationwide

Code Information

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