The Recall Desk
ModerateFDA (Drugs)·D-1021-2013·Announced 2013-09-18

University Compounding Pharmacy Recalls Testosterone CYP Injection Due to Sterility Concerns

University Compounding Pharmacy is voluntarily recalling Testosterone CYP (Sesame Oil) 200mg/mL Injection due to lack of assurance of sterility.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and is a voluntary precautionary recall due to a lack of assurance of sterility, with no reported illnesses or injuries in the source text.

Plain-English summary

University Compounding Pharmacy is voluntarily recalling specific lots of Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vials. The recall is being conducted due to concerns regarding the lack of assurance of sterility for these pharmacy products.

The affected product is distributed nationwide. The specific lots involved are 474323 (Expiration 9/13/2013), 498616 (Expiration 9/25/2013), and 475475 (Expiration 9/26/2013). The total quantity involved is 965.50 mL.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be stopped from use and returned to the pharmacy or manufacturer for disposal or credit.

The recalled product

Product
Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.
Manufacturer
University Compounding Pharmacy
Category
Drug — Injectable Steroid
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 (6)

  • Lot #s: 474323
  • Exp 9/13/2013
  • 498616
  • Exp 9/25/2013
  • 475475
  • Exp 9/26/2013.

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 →

Related recalls

Same manufacturer · University Compounding Pharmacy

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Same hazard · sterility concern

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