The Recall Desk
SevereFDA (Drugs)·D-1447-2016·Announced 2016-08-03

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
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: