Sodium tetradecyl sulfate recalled due to lack of sterility assurance
Specialty Medicine Compounding Pharmacy is recalling sodium tetradecyl sulfate injectable because sterility cannot be assured after a related product was found non-sterile.
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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of infection from non-sterile injectable products.
Plain-English summary
Specialty Medicine Compounding Pharmacy is recalling all unexpired lots of Sodium tetradecyl SO4, 3% injectable. The recall covers products manufactured and distributed between July 1, 2013, and October 19, 2013, including Lot # t08302013@12. The affected product is a prescription-only injectable solution with a quantity of 100 mL.
The recall was initiated because the sterile compounded human and veterinary products were prepared 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 sodium tetradecyl sulfate cannot be assured. The FDA has classified this as a Class II recall.
The product was 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
- Sodium tetradecyl SO4, 3% injectable, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178
- Manufacturer
- Specialty Medicine Compounding Pharmacy
- Category
- Drug — Injectable
- 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 (3)
- All unexpired lots
- manufactured and distributed between 07/01/2013 and 10/19/2013
- including Lot #s: t08302013@12
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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