Class II · Moderate risk Ongoing
Sermorelin Lyophilized powder for reconstitution, 10mg, Vial capacity 10 mL Multi-Dose, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204…
Reason Lack of Assurance of Sterility
Sermorelin Acetate, Lyophilized 6mg Kit 1 Kit 2 Kit; …
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
What was recalled
SERMORELIN ACETATE, LYOPHILIZED 6MG KIT 1 KIT 2 KIT; SERMORELIN ACETATE, LYOPHILIZED 6MG VIAL 2 VIAL; SERMORELIN ACETATE, LYOPHILIZED 9MG KIT 1 KIT 3 KIT 6 KIT; SERMORELIN ACETATE, LYOPHILIZED 9MG VIAL 1 VIAL 2 VIAL 3 VIAL 30 VIAL; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG KIT 1 KIT 3 KIT; SERMORELIN ACETATE/GHRP 2,6 - LYOPHILIZED 9MG/3.15MG/3.15MG VIAL 1 VIAL 3 VIAL 4 VIAL 7 VIAL (16 DIFFERENT PRODUCTS)
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1616-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Sermorelin recalls
See all
Class II · Moderate risk Completed
Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
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…
Class II · Moderate risk Terminated
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave…
Reason Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products…
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