The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0327-2017·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 product lacks assurance of sterility. The recall covers vials prepared between February 2016 and September 2016.

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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by lack of sterility in injectables) fall under the 'Severe' category (Score 4), as Class I is required for Score 5 and Class III for Score 1-2.

Plain-English summary

Wells Pharmacy Network LLC is recalling Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, in 1 mL, 3 mL, 5 mL, and 10 mL vials. The recall was initiated because the product lacks assurance of sterility. The affected vials were compounded by Wells Pharmacy in Ocala, Florida, and prepared between February 22, 2016, and September 14, 2016.

The recall includes specific lot codes for each vial size, all of which are within their expiration dates. The distribution pattern for the recalled product is nationwide. The total quantity of vials involved in the recall is 694 (1 mL), 389 (3 mL), 695 (5 mL), and 5,193 (10 mL).

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Testosterone Cypionate in Grapeseed Oil Injectable, 200 mg/mL, a) 1 mL b) 3 mL c) 5 mL and d) 10 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 (20)

  • All lot codes of product prepared between 02/22/2016 and 09/14/2016
  • within expiry. a) Known lot codes: 03282016@16
  • 03302016@4
  • 04042016@10
  • 04262016@3
  • 05162016@2
  • 06032016@2
  • 07062016@10
  • 08262016@2 b) Known lot code: 04012016@4
  • 04182016@6
  • 04282016@7
  • 05022016@4
  • 06142016@19
  • 08102016@22. c) Known lot code: 04042016@7
  • 05022016@9
  • 05272016@2
  • 06272016@13
  • 07292016@8
  • 08192016@10 d) Known lot code: 03242016@12
  • 04082016@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 →

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