The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0236-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

Qualgen, LLC is recalling specific lots of Testosterone 50mg 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where injury has not yet been reported, meeting the criteria for a High severity score.

Plain-English summary

Qualgen, LLC is recalling specific lots of Testosterone 50mg pellets, available in 1, 6, 12, and 30-count vials, due to a lack of assurance of sterility. The affected products are prescription-only and were distributed nationwide.

The recall involves the following lot numbers and beyond-use dates: C247 (11/30/2018), C249 (12/5/2018), C266 (12/29/2018), D012 (1/12/2019), and D029 (2/2/2019). The NDC codes for these products are 69761-150-01, 69761-150-06, 69761-150-12, and 69761-150-30.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The source text does not specify further instructions for disposal or return.

The recalled product

Product
Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) 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 (5)

  • Lots: C247 BUD: 11/30/2018
  • C249 BUD: 12/5/2018
  • C266 BUD: 12/29/2018
  • D012 BUD: 1/12/2019
  • D029 BUD: 2/2/2019

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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