The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0307-2017·Announced 2017-01-11

FDA Recalls Tri-Coast Pharmacy Testosterone Propionate Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 347 vials of compounded Testosterone Propionate 100 mg/mL because the agency cannot ensure the products are sterile.

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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised, posing a risk of infection.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Testosterone Propionate 100 mg/mL (5 mL) compounded by Tri-Coast Pharmacy. The recall involves 347 vials distributed nationwide. The specific reason for the recall is a lack of assurance of sterility.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes and expiration dates include 07272016A (01/23/2017), 07052016A (12/31/2016), and 11072016A (05/06/2017).

Consumers who have this product should contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. The FDA classifies this as a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
347

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)

  • 07052016A (12/31/2016)
  • 11072016A (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 →

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