FDA Recalls Aluminum Potassium Sulfate Sterile Powder Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant risk factors such as sterility assurance failures in sterile compounded products are categorized as Severe (Score 4).
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Aluminum Potassium Sulfate Sterile powder, a prescription-only product manufactured by Specialty Medicine Compounding Pharmacy in South Lyon, Michigan. The recall covers all unexpired lots of the product that were manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot #s 08132013@1 and 08162013@5. The product quantity is 160 grams.
The recall was initiated due to a lack of assurance of sterility. The FDA states that the affected sterile compounded human and veterinary products were 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 Aluminum Potassium Sulfate Sterile powder cannot be assured.
The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Patients 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
- Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Compounded Sterile Powder
- 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 (4)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 08132013@1
- 08162013@5
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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