Medications & Supplements/Prescription Drugs

FarmaKeio Injectable Medications Recalled for Lack of Sterility Assurance

Agency Publication Date: April 21, 2022

Summary

FarmaKeio Superior Custom Compounding is recalling 1,174 vials of various injectable medications, including BPC-157, Sermorelin, and Melanotan II, because they may not be sterile. The company found manufacturing deviations that call into question the sterility of these products, which are intended to be sterile for safe injection. No illnesses or injuries have been reported to date. These prescription-only (Rx only) medications were distributed nationwide to compounding pharmacies and are used for various medical purposes.

Risk

Injecting a medication that is not sterile can lead to serious, life-threatening infections at the injection site or throughout the body. Because these products are delivered directly into body tissue, any bacterial or fungal contamination poses a severe health risk to patients.

What You Should Do

This recall affects several injectable medications produced by FarmaKeio Superior Custom Compounding, including ARA-290 (Cibinetide Acetate), BPC-157, Ipamorelin Acetate/Sermorelin Acetate, LL-37, Melanotan II, PT-141 (Bremelanotide Acetate), and Sermorelin Acetate.
Identify recalled vials by checking the label for the brand name 'Farmakeio,' the address '1736 N Greenville Ave Richardson, TX 75081,' and the designation 'Rx only.'
Check the lot number and Beyond Use Date (BUD) printed on your medication packaging. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection

Variants: 4 mL vials, Injection

Lot Numbers:

32618 (BUD 4/4/2022)

34525 (BUD 5/24/2022)

Rx only

Product: BPC-157 2 mg/mL (5 mL) Injection

Variants: 5 mL vials, Injection

Lot Numbers:

32242 (BUD 4/19/2022)

33911 (BUD 6/8/2022)

Rx only

Product: Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection

Variants: 10 mL vials, Injection

Lot Numbers:

32961 (BUD 5/12/2022)

Rx only

Product: LL-37 2 mg/mL (5 mL) Injection

Variants: 5 mL vials, Injection

Lot Numbers:

33444 (BUD 4/26/2022)

Rx only

Product: Melanotan II 1 mg/mL (10 mL) Injection

Variants: 10 mL vials, Injection

Lot Numbers:

32610 (BUD 4/4/2022)

35126 (BUD 6/7/2022)

Rx only

Product: PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection

Variants: 2 mL vials, Injection

Lot Numbers:

32616 (BUD 4/4/2022)

34527 (BUD 5/24/2022)

Rx only

Product: Sermorelin Acetate 1 mg/mL (6 mL) Injection

Variants: 6 mL vials, Injection

Lot Numbers:

32963 (BUD 4/12/2022)

34824 (BUD 5/30/2022)

35130 (BUD 6/7/2022)

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89954

Status: Resolved

Manufacturer: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Sold By: FarmaKeio Superior Custom Compounding; Compounding pharmacies

Manufactured In: United States

Units Affected: 7 products (28 vials; 778 vials; 189 vials; 25 vials; 35 vials; 43 vials; 76 vials)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects several injectable medications produced by FarmaKeio Superior Custom Compounding, including ARA-290 (Cibinetide Acetate), BPC-157, Ipamorelin Acetate/Sermorelin Acetate, LL-37, Melanotan II, PT-141 (Bremelanotide Acetate), and Sermorelin Acetate.

Identify recalled vials by checking the label for the brand name 'Farmakeio,' the address '1736 N Greenville Ave Richardson, TX 75081,' and the designation 'Rx only.'

Check the lot number and Beyond Use Date (BUD) printed on your medication packaging. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection

Variants: 4 mL vials, Injection

Lot Numbers:

32618 (BUD 4/4/2022)

34525 (BUD 5/24/2022)

Rx only

Product: BPC-157 2 mg/mL (5 mL) Injection

Variants: 5 mL vials, Injection

Lot Numbers:

32242 (BUD 4/19/2022)

33911 (BUD 6/8/2022)

Rx only

Product: Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection

Variants: 10 mL vials, Injection

Lot Numbers:

32961 (BUD 5/12/2022)

Rx only

Product: LL-37 2 mg/mL (5 mL) Injection

Variants: 5 mL vials, Injection

Lot Numbers:

33444 (BUD 4/26/2022)

Rx only

Product: Melanotan II 1 mg/mL (10 mL) Injection

Variants: 10 mL vials, Injection

Lot Numbers:

32610 (BUD 4/4/2022)

35126 (BUD 6/7/2022)

Rx only

Product: PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection

Variants: 2 mL vials, Injection

Lot Numbers:

32616 (BUD 4/4/2022)

34527 (BUD 5/24/2022)

Rx only

Product: Sermorelin Acetate 1 mg/mL (6 mL) Injection

Variants: 6 mL vials, Injection

Lot Numbers:

32963 (BUD 4/12/2022)

34824 (BUD 5/30/2022)

35130 (BUD 6/7/2022)

Rx only

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89954

Status: Resolved

Manufacturer: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

Sold By: FarmaKeio Superior Custom Compounding; Compounding pharmacies

Manufactured In: United States

Units Affected: 7 products (28 vials; 778 vials; 189 vials; 25 vials; 35 vials; 43 vials; 76 vials)

Distributed To: Nationwide