drugs Class II Updated 2014-01-22

Specialty Medicine Compounding Pharmacy recalls Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx

Recalled Product

Phenylephrine/Tropicamide 2.5 %/1 % ophthalmic solution, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

Hazard / Issue

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Issued by

FDA

Distribution: Hospitals, clinics, physicians, and patients in the Michigan area only.
Lot/Code Info: All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #: 09302013@6
View official government recall

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