Phenylephrine/Tropicamide Ophthalmic Solution Recalled for Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.
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 involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution. The recall affects 6 mL vials manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # 09302013@6.
The recall was initiated because the products were compounded in the same environment and under the same practices as another product found to be non-sterile. Consequently, the sterility of the recalled ophthalmic solution cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
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@6
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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