The Recall Desk
SevereFDA (Drugs)·D-0422-2017·Announced 2017-01-11

Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the product lacks 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 drug recalls involving potential serious health consequences.

Plain-English summary

Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vials. The recall was initiated because the product lacks assurance of sterility. 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 February 22, 2016, and September 14, 2016, that are within their expiration date. Specific known lot codes include 04082016@6, 06012016@6, and 06142016@148. The product quantity involved is 4 vials.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Testosterone Cypionate in Grapeseed Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Hazard
Affected units
4

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 (4)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. Known lot code: 04082016@6
  • 06012016@6
  • 06142016@148

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 →