Ciprodex with Amphoteracin B Ear Drops Recalled for Sterility Concerns
Health Innovations Pharmacy is recalling Ciprodex with Amphoteracin B ear drops due to lack of assurance of sterility and stability data.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score according to the rubric, particularly given the risk to sterility in a medical product.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Ciprodex with Amphoteracin B ear drops. The recall was initiated because recent inspection observations associated with certain quality control procedures present a risk to sterility and quality assurance. Specifically, the lack of assurance of sterility and stability data does not support the product's expiry.
The recall covers all lots of the product. Distribution was limited to North Carolina. Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Ciprodex with Amphoteracin B (ear drops), Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Ophthalmic/Ear Drops
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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