Recall archive / FDA drug enforcement

Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 — FDA record D-0781-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 5, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Classification: Class II
Recalling firm: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Quantity: 76 vials
Agency-reported status: Terminated
Source record identifier: D-0781-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: 32963 BUD: 4/12/2022; 34824 BUD: 5/30/2022; 35130 BUD: 6/7/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within United States

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 27, 2022
Recall initiation date: Apr 5, 2022
Center classification date: Apr 21, 2022
Termination date: Oct 5, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.