Specialty Medicine Compounding Pharmacy Recalls Sterile Compounded Products for Sterility Assurance
Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.
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 the hazard involves a lack of assurance of sterility for compounded products, which poses a significant risk of infection or serious injury.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products. The recall is being conducted because these 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 products cannot be assured.
The affected products include TRANEXAMIC ACID 2 g/75 mL SOLUTION, which is prescription-only. The recall covers all unexpired lots manufactured and distributed between July 1, 2013, and October 19, 2013. Specific lot numbers included in the recall are 08282013@8, 09192013@9, and 10142013@2. The total quantity involved is 3000 mL.
These products were distributed to hospitals, clinics, physicians, and patients in the Michigan area only. Consumers and healthcare providers should stop using these products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- TRANEXAMIC ACID* 2 g/75 mL SOLUTION, 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 (5)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: 08282013@8
- 09192013@9
- 10142013@2
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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