The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0233-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Assurance Concerns

Qualgen, LLC is recalling specific lots of Testosterone 200mg 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is mapped to a score of 4 (Severe).

Plain-English summary

Qualgen, LLC is recalling Testosterone 200mg pellets in 1, 6, 12, and 30-count vials. The recall is being conducted because of a lack of assurance of sterility for the affected product.

The affected lots include C230, C233, C234, C237, C240, C242, C244, C248, C250, C252, C256, C258, C264, D006, D009, D013, D015, D019, D024, D028, D034, D041, D059, D063, and D070. These products were distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone 200mg pellet, 1 count (NDC 69761-120-01), 6 count (NDC 69761-120-06), 12 count (NDC 69761-120-12), and 30 count (NDC 69761-120-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Injectable Steroid
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 (20)

  • Lots: C230 BUD: 11/1/2018
  • C233 BUD: 11/3/2018
  • C234 BUD: 11/9/2018
  • C237 BUD: 11/13/2018
  • C240 BUD: 11/15/2018
  • C242 BUD: 11/20/2018
  • C244 BUD: 11/27/2018
  • C248 BUD: 12/4/2018
  • C250 BUD: 12/6/2018
  • C252 BUD: 12/12/2018
  • C256 BUD: 12/14/2018
  • C258 BUD: 12/18/2018
  • C264 BUD: 12/27/2018
  • D006 BUD: 1/8/2019
  • D009 BUD: 1/10/2019
  • D013 BUD: 1/15/2019
  • D015 BUD: 1/17/2019
  • D019 BUD: 1/22/2019
  • D024 BUD: 1/29/2019
  • D028 BUD: 2/1/2019

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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