The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0400-2017·Announced 2017-01-11

Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

Wells Pharmacy is recalling Testosterone Cypionate in Grapeseed Oil Injectable vials because the agency could not ensure the product was sterile.

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 conditions.

Plain-English summary

Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, in 1 mL and 5 mL vials. The recall was initiated due to a lack of assurance of sterility. The affected products were compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide.

The recall includes 303 vials of the 1 mL size and 413 vials of the 5 mL size. All lot codes for product prepared between February 22, 2016, and September 14, 2016, within their expiry dates, are affected. Specific known lot codes include 04212016@5, 05102016@123, 05232016@21, and 07132016@18 for the 1 mL vials, and 04142016@7, 05042016@6, 05252016@2, 06222016@30, 07132016@25, and 07282016@5 for the 5 mL vials.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product
Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer
Wells Pharmacy Network LLC
Category
Drug — Compounded Injectable
Hazard

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 (10)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. a) Known lot code: 04212016@5
  • 05102016@123
  • 05232016@21
  • 07132016@18 b) Known lot code: 04142016@7
  • 05042016@6
  • 05252016@2
  • 06222016@30
  • 07132016@25
  • 07282016@5.

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 →

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