D-0990-2022 Class II Terminated
FDA drug recall D-0990-2022 was initiated by Grato Holdings, Inc. on May 24, 2022 and is designated Class II. Reason for recall: Microbial contamination of non-sterile product. The recall status is terminated (terminated June 8, 2023). Affected quantity: 50,640 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- June 15, 2022
- Initiation Date
- May 24, 2022
- Termination Date
- June 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50,640 bottles
Product Description
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
Reason for Recall
Microbial contamination of non-sterile product.
Distribution Pattern
Nationwide within the USA
Code Information
Lot #: G11639, Exp. Date 09/24