Homeopathic EarAche Ear Drops Recalled for Microbial Contamination
CVS Pharmacy is recalling Homeopathic EarAche Ear Drops (lot #G11639, exp. 09/24) due to microbial contamination detected in the non-sterile product. Consumers should stop using affected bottles.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this as a Class II recall involving a non-sterile product with documented microbial contamination. Although no illnesses or injuries are reported in the source, the risk-of-harm profile—contamination in a product for ear use near mucous membranes—meets the rubric criterion for High severity.
Plain-English summary
Grato Holdings, Inc., distributed by CVS Pharmacy, Inc., is recalling Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, nationwide. The recall affects approximately 50,640 units with lot number G11639 and expiration date 09/24 (NDC 59779-568-15).
The product has been found to contain microbial contamination. Because these ear drops are non-sterile and intended for use in or near the ear, the microbial contamination poses a potential health risk.
The affected product was distributed nationwide within the United States. Consumers who have purchased this product should discontinue use immediately. Consumers with questions or concerns should consult their healthcare provider.
The recalled product
- 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
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Ear Drops
- Hazard
- microbial-contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: G11639
- Exp. Date 09/24
Distribution
Distributed nationwide across the United States.
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