The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0298-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Cypionate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 400 vials of compounded Testosterone Cypionate in Sesame because the products lack 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving potential serious health consequences.

Plain-English summary

Tri-Coast Pharmacy is recalling 400 vials of Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). The recall is due to 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. Known lot codes include 05122016B (expiration date 11/18/2016), 08012016C (expiration date 01/28/2017), and 09262016D (expiration date 03/25/2017). The products were distributed nationwide.

Consumers should check their medication for these specific lot codes and contact their healthcare provider or pharmacist for guidance on next steps.

The recalled product

Product
Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
400

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 (2)

  • 08012016C (01/28/2017)
  • 09262016D (03/25/2017).

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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