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.
D-0419-2015
Product summary
- Event
- Event 70577
- Status
- Terminated
- Classification
- Class II
- Quantity
- 78,591 bottles
- Official record key
drug-enforcement:D-0419-2015
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Code information: Lot #: 7599 (Refer to lot 13L0009), 7600 (Refer to lot 13K0014), 7622 (Refer to lot 13L0008), 7623 (Refer to lot 13K0015), Exp 10/15
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination