Sermorelin Acetate Injection Recalled Due to Sterility Assurance Issues
Sermorelin Acetate injectable (76 vials) recalled nationwide due to manufacturing deviations that compromise sterility assurance. No illnesses reported.
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: FDA Class II recall for a sterile injectable product with manufacturing deviations that call sterility into question. This is a risk-of-harm product where no illnesses or injuries have been reported, placing it at the High severity level per the rubric.
Plain-English summary
North American Custom Laboratories, LLC (dba FarmaKeio Superior Custom Compounding) is recalling Sermorelin Acetate 1 mg/mL injection in 6 mL vials due to a lack of assurance of sterility. The recall affects 76 vials with lot numbers 32963 (BUD 4/12/2022), 34824 (BUD 5/30/2022), and 35130 (BUD 6/7/2022). This prescription injectable was distributed nationwide.
The FDA determined that deviations from Current Good Manufacturing Practices (CGMP) call into question whether the product meets sterility requirements. Because this is a sterile injectable medication intended for direct administration to patients, any compromise in sterility assurance poses a potential infection risk.
Patients who have received this product should contact their healthcare provider or pharmacist immediately. The medication should not be used and should be returned to the pharmacy or disposed of according to local pharmaceutical waste guidelines.
The recalled product
- Product
- Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
- Category
- Drug — Injectable / Prescription
- Affected units
- 76
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 (3)
- Lot #: 32963 BUD: 4/12/2022
- 34824 BUD: 5/30/2022
- 35130 BUD: 6/7/2022
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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