The Recall Desk
SevereFDA (Drugs)·D-1166-2016·Announced 2016-07-13

Vital Care Compounder Recalls Testosterone Cypionate Due to Sterility Concerns

Vital Care Compounder is recalling 13 units of Testosterone Cypionate 200mg/ml because aluminum crimps may not fully seal the vials, compromising sterility.

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, which corresponds to a Severe rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

Vital Care Compounder, LLC is recalling 13 units of Testosterone Cypionate 200mg/ml, 1ML MDV. The product was distributed in Mississippi. The specific lot number is 382331, with a use-by date of 12-11-16.

The recall was initiated due to a lack of assurance of sterility. The FDA notes that aluminum crimps do not fully seal the rubber stopper to the vial on all containers, which could compromise the sterility of the medication.

Consumers who have this product should stop using it and contact Vital Care Compounder, LLC for further instructions or a refund.

The recalled product

Product
TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
Affected units
13

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#:382331
  • Use by 12-11-16

Distribution

Distributed in 1 state: