FDA recall D-311-2013

Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals · Class II · drug

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.

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

Nationwide

Key facts

Status
Terminated
Initiation date
2013-03-16
Report date
2013-05-08
Termination date
2013-06-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-311-2013