Medicap Pharmacy Recalls Acetylcyst 10% Ophthalmic Solution for Sterility Concerns
Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution because sterile products were not produced in a controlled, sterile environment.
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 assurance of sterility for a sterile product, which poses a significant risk of infection.
Plain-English summary
Medicap Pharmacy is recalling Acetylcyst 10% Ophthalmic Solution, 10%, 15 mL bottles. The recall was initiated because the sterile products were not produced in a controlled, sterile environment.
The affected product is identified by Lot # 05092016@19, with a Beyond Use Date of 06/08/16 and a Discard After date of 09/01/2017. The product is prescription-only and was distributed in Idaho.
Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to proceed.
The recalled product
- Product
- Acetylcyst 10% OPHT SOL, 10%, 15 mL bottle, Rx only, Medicap Pharmacy, 2790 W Cherry Lane, Meridian, ID 83642, NDC 99999-9996-94.
- Manufacturer
- Medicap Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 1
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 (3)
- Lot #: 05092016@19
- Beyond Use Date: 06/08/16
- Discard After 09/01/2017.
Distribution
Distributed in 1 state:
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