The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0238-2019·Announced 2018-11-14

Qualgen Testosterone and Anastrozole Pellets Recalled for Sterility Concerns

Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets due to a lack of assurance of sterility. The recall affects specific vial sizes distributed nationwide.

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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk scenarios.

Plain-English summary

Qualgen, LLC is recalling Testosterone 200 mg/Anastrozole 20 mg pellets in 1, 6, 12, and 30 count vials. The recall is being conducted due to a lack of assurance of sterility. The affected product is prescription-only and was distributed nationwide.

The recall involves lot C254 with a beyond-use date of 12/13/2018. The product is identified by NDC numbers 69761-222-01, 69761-222-06, 69761-222-12, and 69761-222-30. Qualgen, LLC is the recalling firm located in Edmond, OK.

Consumers and healthcare providers should check their inventory for the specific lot number and beyond-use date listed above. If the product matches the recalled lot, it should be returned to the pharmacy or supplier for disposal or replacement according to standard recall procedures.

The recalled product

Product
Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Injectable 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 (1)

  • Lot: C254 BUD: 12/13/2018

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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