Drug product
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
D-0991-2022
Product summary
- Event
- Event 90297
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,872 bottles
- Official record key
drug-enforcement:D-0991-2022
Official wording
Reason: Microbial contamination of non-sterile product.
Code information: Lot #: G11639, Exp. Date 09/24
Distribution pattern: Nationwide within the USA
Derived failure modes
-
Microbial contamination
Microbial contamination