Recall of Testosterone 12.5mg Pellet due to Sterility Concerns
Qualgen, LLC is recalling Testosterone 12.5mg pellets nationwide because the sterility of the product cannot be assured. Consumers should stop using the affected lots and contact the manufacturer or pharmacist.
What this means for you
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: FDA Class II recall for an injectable drug with a lack of sterility assurance. No illnesses or injuries have been reported, but the product presents a theoretical risk of serious infection, meeting the criteria for a High severity risk-of-harm product.
Plain-English summary
Qualgen, LLC is recalling specific lots of Testosterone 12.5mg pellets, an injectable prescription medication. The affected lots are C261 with a beyond-use date of December 20, 2018. The product is supplied in vials of 1, 6, 12, and 30 counts (NDCs 69761-112-01, 69761-112-06, 69761-112-12, and 69761-112-30).
The recall is due to a lack of assurance of sterility. The manufacturer could not guarantee that the product was produced under sterile conditions, which poses a risk of infection if administered.
The recall affects the nationwide distribution of the product. Patients who have the affected lots should stop using them immediately and return them to the pharmacy or contact the manufacturer for replacement. Healthcare providers should also be aware of the recall when treating patients using this medication.
The recalled product
- Product
- Testosterone 12.5mg pellet, 1 count (NDC 69761-112-01), 6 count (NDC 69761-112-06), 12 count (NDC 69761-112-12), and 30 count (NDC 69761-112-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
- Manufacturer
- Qualgen, LLC
- Category
- Drug
- 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)
- Lots: C261 BUD: 12/20/2018
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 →Related recalls
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