The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0300-2017·Announced 2017-01-11

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

Tri-Coast Pharmacy is recalling 7,168 vials of compounded Testosterone Cypionate in Sesame Oil because the FDA determined there was 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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectable drugs) are classified as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Tri-Coast Pharmacy is recalling 7,168 vials of Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). The recall was initiated because the U.S. Food and Drug Administration determined there was a lack of assurance of sterility for the product.

The recall includes all sterile products compounded by Tri-Coast Pharmacy between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including lots such as 05252016A, 06272016B, and 07262016D.

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 violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
7,168

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)

  • 06272016B (12/24/2016)
  • 07262016D (01/22/2017)
  • 07182016H (01/14/2017)
  • 07182016G (01/14/2017)
  • 08252016C (02/21/2017)
  • 08222016B (02/18/2017)
  • 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 →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · sterility

See all →

Similar recalls