The Recall Desk
HighFDA (Drugs)·D-1293-2015·Announced 2015-08-12

Apothecary Shoppe Recalls Testosterone Cypionate Injection Due to Sterility Concerns

The Apothecary Shoppe is recalling specific lots of Testosterone Cypionate Injection due to a lack of documentation confirming proper environmental monitoring during production.

What this means for you

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 is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a risk of harm even though specific injuries are not reported in the source text.

Plain-English summary

The Apothecary Shoppe LLC is recalling specific lots of SIH-Testosterone Cyp. 20 mg/mL Injection, a prescription-only medication available in 10 mL vials. The recall is limited to products distributed in Oklahoma.

The recall was initiated due to a lack of assurance of sterility. The company identified that documentation for proper environmental monitoring during the time the medication was produced was missing. This documentation gap prevents verification that the sterile conditions required for the product were maintained.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The affected lots are identified by the following codes: 04202015@33 with a beyond-use date of 8/18/2015, and 04272015@18 with a beyond-use date of 8/25/2015.

The recalled product

Product
SIH-Testosterone Cyp. 20 mg/mL Injection, Rx Only, 10 mL Vial, Apothecary Shoppe, Compounding Pharmacy, Tulsa OK 74135, NDC 13452-2896-05

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 #: 04202015@33
  • BUD 8/18/2015
  • 04272015@18
  • BUD 8/25/2015

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 28 recalled by The Apothecary Shoppe LLC 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 28 products in this recall →