The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0306-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Suspension Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 13 vials of compounded Testosterone Suspension 100 mg/mL due to a lack of assurance of sterility. The recall covers products compounded between May and November 2016.

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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is compromised, even without reported hospitalizations in the text.

Plain-English summary

Tri-Coast Pharmacy is recalling 13 vials of Testosterone Suspension 100 mg/mL (5 mL) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. One known lot code is 06292016C, with an expiration date of October 28, 2016.

The recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with the product. The distribution pattern is listed as nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
13

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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