FDA recall D-0991-2022
Grato Holdings, Inc. · Class II · 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
Reason for recall
Microbial contamination of non-sterile product.
Distribution
Nationwide within the USA
Key facts
- Status
- Terminated
- Initiation date
- 2022-05-24
- Report date
- 2022-06-15
- Termination date
- 2023-06-08
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Woodbine, IA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0991-2022