The Recall Desk
SevereFDA (Drugs)·D-0399-2017·Announced 2017-01-11

Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 266 vials of compounded Testosterone Cypionate Injectable due to a lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Wells Pharmacy Network LLC is recalling 266 vials of Testosterone Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial. The recall is being conducted because of a lack of assurance of sterility in the product.

The affected product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall includes all lot codes of the product prepared between 02/22/2016 and 09/14/2016, within expiry. Known lot codes include 04012016@2, 05052016@4, 06022016@13, 06102016@35, and 07052016@6.

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 Cypionate / Zinc Sulf in Grapeseed Oil Injectable, 200 mg/200 mcg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Hazard
Affected units
266

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 (6)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 04012016@2
  • 05052016@4
  • 06022016@13
  • 06102016@35
  • 07052016@6.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 97 recalled by Wells Pharmacy Network LLC 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 97 products in this recall →