Proparacaine HCl Ophthalmic Solution Recalled for Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Proparacaine HCl ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
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. According to the rubric, an FDA Class II recall involving a risk of harm (loss of sterility) where injury has not yet been reported is categorized as Severe.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Proparacaine HCl PF, 0.5% ophthalmic solution. The recall is being conducted because the sterile compounded products were manufactured in the same environment and under the same practices as another product that was found to be non-sterile. Consequently, the sterility of the recalled Proparacaine HCl solution cannot be assured.
The affected product is a 6 mL prescription-only ophthalmic solution. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, specifically including Lot # 09302013@8. The products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only.
Consumers and healthcare providers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Proparacaine HCl PF, 0.5% ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
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)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #: 09302013@8
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Specialty Medicine Compounding Pharmacy 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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