US Compounding Recalls Acetylcysteine 10% Ophthalmic Solution for Sterility Concerns
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic solution due to deficient practices that may impact sterility assurance.
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, and the hazard involves a lack of sterility assurance in a sterile preparation, which poses a significant risk of infection or injury.
Plain-English summary
US Compounding Inc is recalling Acetylcysteine 10% Ophthalmic, 10 mL dropper bottles, for topical ophthalmic use. The recall involves three dropper bottles with lot numbers 20150209@41 (BUD: 10/2/2015) and 20150909@2 (BUD: 10/9/2015). The product was distributed nationwide.
The recall was initiated due to a lack of assurance of sterility. The firm identified deficient practices that may have an impact on sterility assurance for all sterile preparations within their expiry dates.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- ACETYLCYSTEINE 10% OPHTALMIC, 10 mL dropper bottle; For topical ophthalmic use, Rx.only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032.
- Manufacturer
- US Compounding Inc
- Category
- Drug — Ophthalmic
- Affected units
- 3
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 Numbers: 20150209@41 BUD: 10/2/2015
- 20150909@2 BUD: 10/9/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 59 recalled by US Compounding 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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