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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

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.
Recall Number D-311-2013
Classification Class II
Code Info Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
Product Distributed Qty 13,369 bottles (12oz), 2607 bottles (26oz)
Reason For Recall Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.

Event Detail

Event Id 64963
Product Type Drugs
Status Ongoing
Recalling Firm Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals
City Miami Gardens
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-16
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Nationwide
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