Ipamorelin and Sermorelin Injectable Medications Recalled Due to Sterility Deviations
North American Custom Laboratories is recalling 189 vials of Ipamorelin/Sermorelin injectable due to manufacturing deviations that call into question the sterility of this prescription medication.
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: This FDA Class II recall addresses manufacturing deviations that call into question the sterility of injectable medications. As a risk-of-harm situation with no illnesses or injuries reported in the source material, this meets the rubric criteria for a High severity rating.
Plain-English summary
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding is recalling 189 vials of Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL injection, 10 mL vials (Lot #32961, BUD 5/12/2022). The affected vials were distributed nationwide within the United States.
The recall is due to deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of these products. These are prescription injectable medications intended to be sterile, and the manufacturing deviations have raised concerns about product sterility assurance.
This recall was issued by the U.S. Food and Drug Administration and classified as a Class II recall (FDA recall number D-0777-2022).
The recalled product
- Product
- Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
- Affected units
- 189
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 #: 32961 BUD: 5/12/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding 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.
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