The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0297-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Testosterone Cypionate Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 166 vials of compounded Testosterone Cypionate in Sesame 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterile injection) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Tri-Coast Pharmacy is recalling 166 vials of Testosterone Cypionate in Sesame, 100 mg/mL (5 mL), compounded by the firm. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The distribution pattern is nationwide. Known lot codes and expiration dates include 07152016A (01/11/2017), 08182016A (02/14/2017), and 09282016J (03/27/2017).

Consumers should check their medication for these specific lot codes and dates. If the product matches the description, they should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone Cypionate in Sesame, 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
166

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)

  • 08182016A (02/14/2017)
  • 09282016J (03/27/2017).

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 →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · lack of sterility

See all →

Similar recalls