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.
What this means for you
Illness, injury, or structural failure has been reported. 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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