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.
D-311-2013
Product summary
- Event
- Event 64963
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,369 bottles (12oz), 2607 bottles (26oz)
- Official record key
drug-enforcement:D-311-2013
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
Code information: Lot Number #:13B0023; exp 02/15 FP-4809 (12oz) FP-4810 (26oz)
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination