Agency classClass IIOur severity:Severe FDA (Drugs)·D-0338-2017·Announced 2017-01-11

Wells Pharmacy Recalls Testosterone Cypionate Injectable Due to Sterility Concerns

Wells Pharmacy Network LLC is recalling 21 vials of Testosterone Cypionate in Sesame Oil Injectable 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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in injectables) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.

Plain-English summary

Wells Pharmacy Network LLC is recalling 21 vials of Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial. The product was compounded by Wells Pharmacy in Ocala, Florida, and distributed nationwide. The recall involves all lot codes of the product prepared between February 22, 2016, and September 14, 2016, that are within their expiration date. One known lot code is 03312016@9.

The recall was initiated due to a lack of assurance of sterility. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Consumers and healthcare providers who have this product should stop using it and contact their pharmacist or the recalling firm for instructions on return or disposal. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product: Testosterone Cypionate in Sesame Oil Injectable, 210 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Manufacturer: Wells Pharmacy Network LLC
Category: Drug — Injectable Steroids
Hazard: sterility
infection
Affected units: 21

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 (2)

All lot codes of product prepared between 02/22/2016 and 09/14/2016
within expiry. Known lot code: 03312016@9

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 →

Same manufacturer · Wells Pharmacy Network LLC

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Same hazard · sterility