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.
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 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
- 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.
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