Recalls / Class II
Class IID-0990-2022
Product
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
- Affected lot / code info
- Lot #: G11639, Exp. Date 09/24
Why it was recalled
Microbial contamination of non-sterile product.
Recalling firm
- Firm
- Grato Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 201 Apple Blvd, Woodbine, Iowa 51579-1503
Distribution
- Quantity
- 50,640 bottles
- Distribution pattern
- Nationwide within the USA
Timeline
- Recall initiated
- 2022-05-24
- FDA classified
- 2022-06-08
- Posted by FDA
- 2022-06-15
- Terminated
- 2023-06-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0990-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.