The Recall Desk
SevereFDA (Drugs)·D-0303-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Cypionate/Propionate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 152 vials of compounded Testosterone Cypionate/Propionate because the agency cannot assure the products are sterile.

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, and the hazard involves a lack of assurance of sterility in an injectable drug, which poses a significant risk of serious injury or infection.

Plain-English summary

Tri-Coast Pharmacy is recalling 152 vials of Testosterone Cypionate/Propionate, 200 mg/50 mg/mL (5 mL). The recall is due to a lack of assurance of sterility for the compounded products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes are 07132016D (expiration date 01/09/2017) and 11072016B (expiration date 05/06/2017). The products were distributed nationwide.

Consumers should stop using the recalled products and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
Testosterone Cypionate/Propionate, 200 mg/50 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Affected units
152

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 (1)

  • 11072016B (05/06/2017).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 80 recalled by Tri-Coast 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 80 products in this recall →