The Recall Desk
SevereFDA (Drugs)·D-1027-2013·Announced 2013-09-18

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.

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. 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
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

Distributed in 2 states:

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.

See all 3 products in this recall →