Agency classClass IIOur severity:High FDA (Drugs)·D-0778-2022·Announced 2022-04-27

Injectable Drug Recalled Due to Sterility Assurance Concerns

North American Custom Laboratories is recalling LL-37 2 mg/mL injectable vials due to manufacturing process deviations that raise questions about product sterility. The company distributed 25 vials nationwide.

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: This is a Class II recall of a sterile injectable drug with manufacturing defects that call into question product sterility. Although no illnesses or injuries have been reported, injectable products that lack sterility assurance present a clear risk of serious infection, meeting the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

North American Custom Laboratories, LLC (doing business as FarmaKeio Superior Custom Compounding) is recalling LL-37 2 mg/mL Injection, supplied in 5 mL vials. The recall affects Lot #33444 with a beyond-use date of 4/26/2022.

The company initiated this recall because deviations from Current Good Manufacturing Practices (CGMP) have raised questions about whether the sterile product actually maintains its required sterility. Sterile injectable products must meet strict manufacturing standards to prevent contamination that could cause serious infections.

The company distributed 25 vials nationwide within the United States. Patients who have received this medication should contact their healthcare provider immediately. Individuals who still have this product should not use it and should consult with their pharmacist or healthcare provider about proper handling and disposal.

The recalled product

Product: LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Manufacturer: North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Category: Drug — Injectable / Sterile Preparation
Hazard: sterility-assurance
manufacturing-defect
Affected units: 25

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 #: 33444 BUD: 4/26/2022

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.

See all 7 products in this recall →

Same manufacturer · North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding

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