The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1022-2013·Announced 2013-09-18

University Compounding Pharmacy Recalls Testosterone Injection Due to Sterility Concerns

University Compounding Pharmacy is voluntarily recalling Testosterone Cypionate/Testosterone Propionate Injection due to 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (sterility failure in an injectable drug) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

University Compounding Pharmacy is voluntarily recalling certain pharmacy products, specifically Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial. The recall is being conducted due to lack of assurance of sterility concerns.

The affected product is identified by Lot 513593 with an expiration date of 11/30/2013. The product quantity is 70 mL. The distribution pattern is listed as nationwide.

Consumers should stop using the recalled product and contact University Compounding Pharmacy at 855-398-1800 for further instructions or a refund.

The recalled product

Product
Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

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 513593
  • Exp11/30/2013

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by University 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.

See all 5 products in this recall →

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