D-311-2013 Class II Terminated
FDA drug recall D-311-2013 was initiated by Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals on March 16, 2013 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination. The recall status is terminated (terminated June 25, 2013). Affected quantity: 13,369 bottles (12oz), 2607 bottles (26oz).
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)