Specialty Medicine Compounding Pharmacy Recalls Glutathione PF Inhalation Solution
Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are Severe. While no specific injuries are reported, the loss of sterility assurance in a compounded injectable/inhalation product represents a significant risk of serious harm, aligning with the Severe criteria for high-risk contamination.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Glutathione PF, 60 mg/mL inhalation, a prescription-only sterile compounded product. The recall is being conducted because the product was compounded 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 Glutathione PF cannot be assured.
The affected product is a 126 mL inhalation solution. The recall includes all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, specifically including Lot # 10112013@1. 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 how to return or dispose of the medication.
The recalled product
- Product
- Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
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 #: 10112013@1
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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