The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0237-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets nationwide 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 and involves a lack of assurance of sterility for a drug product, which aligns with the rubric criteria for Severe severity (FDA Class II with potential for significant injury).

Plain-English summary

Qualgen, LLC is recalling specific lots of Testosterone 87.5mg pellets, available in 1, 6, 12, and 30-count vials. The recall is being conducted due to a lack of assurance of sterility for the affected product.

The affected lots are C243 (Best Use Date: 11/21/2018), D010 (Best Use Date: 1/11/2019), and D025 (Best Use Date: 1/30/2019). The product was distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The recall is classified as FDA Class II.

The recalled product

Product
Testosterone 87.5mg pellet, 1 count (NDC 69761-187-01), 6 count (NDC 69761-187-06), 12 count (NDC 69761-187-12), and 30 count (NDC 69761-187-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Testosterone Pellets
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 (3)

  • Lots: C243 BUD: 11/21/2018
  • D010 BUD: 1/11/2019
  • D025 BUD: 1/30/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 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 14 products in this recall →

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