The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0893-2018·Announced 2018-07-11

Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates

Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to documentation and labeling errors.

Plain-English summary

Qualgen, LLC is recalling Testosterone 200 mg Pellets, 1-count 3ml amber vials, due to labeling errors. The affected product is compounded by Qualgen, LLC, located in Edmond, Oklahoma, and is identified by NDC 69761-120-01.

The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The specific lot number is D001, with an expiration date of 01/02/2018 and a compounded date of 01/02/2019. The product was distributed nationwide in the USA.

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.

The recalled product

Product
TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
Manufacturer
Qualgen, LLC
Category
Drug — Compounded Prescription
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 (1)

  • lot# D001 EXP: 01/02/2018 CPD: 01/02/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Qualgen, 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 2 products in this recall →

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