Specialty Medicine Compounding Pharmacy Recalls Testos Cypionate Injectable Due to Sterility Concerns
Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterility assurance issues for injectable products.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Testos Cypionate in Oil 100 mg/mL and 200 mg/mL injectable. The recall covers products manufactured and distributed between July 1, 2013, and October 19, 2013, including specific lot numbers 09182013@42, t09172013@31, and t09182013@4. The affected products were distributed to hospitals, clinics, physicians, and patients in the Michigan area.
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 Testos Cypionate products cannot be assured. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers who have received these products should stop using them and contact their healthcare provider or the pharmacy for further instructions. The recall is limited to the Michigan area and affects both human and veterinary compounded sterile products from the same facility during the specified period.
The recalled product
- Product
- TESTOS CYPIONATE* IN OIL 100 mg/mL INJECTABLE, TESTOS CYPIONATE* IN OIL 200 mg/mL INJECTABLE, 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: 09182013@42
- t09172013@31
- t09182013@4
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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