LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Reported: April 27, 2022 Initiated: April 5, 2022 #D-0778-2022
Product Description
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Reason for Recall
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Details
- Units Affected
- 25 vials
- Distribution
- Nationwide within United States
- Location
- Richardson, TX
Frequently Asked Questions
What product was recalled? ▼
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA. Recalled by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding. Units affected: 25 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 27, 2022. Severity: Moderate. Recall number: D-0778-2022.
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