FDA recall D-0419-2015

Tarmac Products, Inc. · Class II · drug

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.

Reason for recall

Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2015-02-06
Report date
2015-03-25
Termination date
2016-12-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami Gardens, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0419-2015