Polidocanol Injectable Recalled Due to Lack of Sterility Assurance
Specialty Medicine Compounding Pharmacy is recalling Polidocanol 3% injectable 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 recall is classified as FDA Class II and involves a lack of sterility assurance for an injectable product, which poses a significant risk of infection or serious injury.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling Polidocanol, 3% injectable, Rx only. The recall covers all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # t07312013@28. The product is a 10 mL sterile compounded medication.
The recall was initiated because the 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 Polidocanol 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
- Polidocanol, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Injectable
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 #: t07312013@28
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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