The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0126-2017·Announced 2016-11-16

FDA Recalls Wells Pharmacy Testosterone and Anastrozole Pellets

Wells Pharmacy Network is recalling compounded Testosterone 200 mg/Anastrozole 9 mg Pellets because they are superpotent or subpotent.

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 agency classification is FDA Class II, which corresponds to a 'Severe' rating (score 4) under the rubric, as it involves a potential health risk that may require medical treatment.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling Testosterone 200 mg/Anastrozole 9 mg Pellets compounded by Wells Pharmacy Network, LLC. The recall involves 690 pellets distributed in the U.S. The specific lots affected are identified by the following lot numbers and beyond-use dates: Lot 04072016@4 (BUD 10/04/2016), Lot 06162016@2 (BUD 12/03/2016), and Lot CA07112016@4 (BUD 01/07/2017).

The reason for the recall is that the products are classified as superpotent and subpotent drugs. This means the medication may contain more or less of the active ingredient than intended, which can affect its safety and effectiveness.

Consumers who have these specific pellets should stop using them and contact their healthcare provider or pharmacist for instructions on how to dispose of the product or obtain a replacement.

The recalled product

Product
Testosterone 200 mg/Anastrozole 9 mg Pellet, Compounded by: Wells Pharmacy Network
Manufacturer
Wells Pharmacy Network, LLC
Category
Drug — Compounded Medication
Hazard
Affected units
690

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)

  • BUD: 10/04/2016
  • Lot number 04072016@40 BUD: 12/03/2016
  • Lot number 06162016@2 BUD: 01/07/2017
  • Lot number CA07112016@4

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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