The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0783-2017·Announced 2017-05-24

Key Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.

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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe. While no specific injuries are reported in the text, the lack of sterility assurance in a compounded injectable drug represents a significant risk of serious harm, aligning with the Severe criteria for Class II recalls with potential for significant injury.

Plain-English summary

Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection, 50mg/mL, packaged in 5mL and 10mL glass multiple-dose vials. The recall involves a total of 6 vials: five 5mL vials and one 10mL vial.

The recall was initiated because the firm lacks assurance of the sterility of the compounded drugs. The affected products are within their expiration dates. The specific lots involved are t02-09-2017@79 (expiring 5/14/2017) and t02-22-2017@91 (expiring 5/24/2017).

The product was distributed nationwide in the U.S.A., as well as in Australia and Canada. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.

The recalled product

Product
TESTOST AQ MDV 50MG/ML INJ, Injection, 50mg/mL, Rx only, packaged in 5mL and 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
Manufacturer
Key Pharmacy and Compounding Center
Category
Drug — Compounded Sterile Drug
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 (4)

  • Lot # t02-09-2017@79
  • Exp 5/14/2017
  • t02-22-2017@91
  • Exp 5/24/2017

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 79 recalled by Key Pharmacy and Compounding Center 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 79 products in this recall →

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