The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0305-2017·Announced 2017-01-11

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

Tri-Coast Pharmacy is recalling 1,567 vials of compounded Testosterone Enanthate in Sesame Oil 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 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' rating under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 1,567 vials of Testosterone Enanthate in Sesame Oil, 200 mg/mL (5 mL). The recall was initiated because the agency identified a lack of assurance of sterility for the product.

The affected products were compounded between May 17, 2016, and November 17, 2016. The recall includes specific lot codes with expiration dates ranging from January 9, 2017, to April 30, 2017. The products were distributed nationwide.

Consumers and healthcare providers should check their inventory for the specific lot codes listed in the recall notice. If the product is found, it should be discontinued and returned to the pharmacy or disposed of according to local regulations. Patients who have already used the product should consult their healthcare provider if they have concerns.

The recalled product

Product
Testosterone Enanthate 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
1,567

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 (5)

  • 08122016A (02/28/2017)
  • 11012016J (04/30/2017)
  • 07132016G (01/09/2017)
  • 09012016B (02/28/2017)
  • 09272016A (03/26/2017).

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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