The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0301-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 1,544 vials of compounded Testosterone Cypionate/Zinc Gluconate in Sesame Oil nationwide due to a 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe).

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 1,544 vials of Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, in 5 mL and 10 mL sizes. The recall is being conducted because of a lack of assurance of sterility for the compounded products.

The affected products were compounded between May 17, 2016, and November 17, 2016, and were distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring between January 2017 and April 2017.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
1,544

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 (13)

  • 07132016C (01/09/2017)
  • 08302016A (02/26/2017)
  • 08042016D (01/31/2017)
  • 11012016K (04/30/2017)
  • 09202016D (03/19/2017)
  • 10032016B (04/01/2017)
  • 08102016A (02/06/2017)
  • 09282016D (03/27/2017)
  • 09222016E (03/21/2017)
  • 09152016A (02/28/2017)
  • 09062016B (02/28/2017)
  • 10252016C (02/28/2017)
  • 10042016E (04/02/2017).

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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