The Recall Desk
SevereFDA (Drugs)·D-0299-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 2,818 vials of compounded Testosterone Cypionate in Grapeseed nationwide due to a lack of assurance of sterility.

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 2,818 vials of Testosterone Cypionate in Grapeseed, 200 mg/mL, in 5 mL and 10 mL sizes. The recall is being conducted because of a lack of assurance of sterility in the compounded products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including codes such as 05232016D, 06162016A, and 11022016C.

Consumers who have these products should stop using them and contact their healthcare provider or the pharmacy for further instructions.

The recalled product

Product
Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Injectable
Hazard
Affected units
2,818

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 (11)

  • 06162016A (12/13/2016)
  • 06132016A (12/10/2016)
  • 07282016I (01/24/2017)
  • 08172016D (02/13/2017)
  • 08042016C (01/31/2017)
  • 09222016F (03/21/2017)
  • 09062016A (02/28/2017)
  • 10272016B (02/28/2017)
  • 10252016D (02/28/2017)
  • 08252016B (02/21/2017)
  • 11022016C (05/01/2017).

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 →

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