Testosterone Cypionate Injection Recalled for Lack of Sterility Assurance
South Coast Specialty Compounding is voluntarily recalling Testosterone Cypionate injections due to a lack of sterility assurance.
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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard such as lack of sterility assurance in an injectable drug corresponds to a Severe severity score.
Plain-English summary
South Coast Specialty Compounding, Inc. is voluntarily recalling one lot of Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials. The recall is being conducted due to a lack of assurance of sterility.
The affected product is identified by Lot #05072013@1 with an expiration date of 11/3/2013. A total of 117 vials were distributed to locations in California and Indiana.
Consumers who possess this specific lot of Testosterone Cypionate should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Testosterone Cypionate (Sesame Oil) 200mg/mL for injection in 10mL amber vials, Park Compounding, Irvine, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Injectable
- Hazard
- Affected units
- 117
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 (2)
- Lot #05072013@1
- Exp 11/3/2013
Distribution
Part of a larger recall action
This product is one of 3 recalled by South Coast Specialty Compounding, Inc. 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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