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
Is Sermorelin recalled?
92 FDA recalls mention Sermorelin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Sermorelin.
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…
Class II · Moderate risk Terminated
Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b)…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
Class II · Moderate risk Terminated
Sermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile…
Reason Sub Potent
Class II · Moderate risk Ongoing
Sermorelin/Glycine 2000mcg/5mg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sermorelin/Glycine 2000mcg/5mg/mL, 4mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Sermorelin 2000mcg/mL, 7.5mL-vial, Refrigerate, Tailor Made Compounding
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
SERMORELIN ACETATE 9MG/IPAMORELIN 9MG - LYOPHILIZED 9MG/9MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
SERMORELIN ACETATE 6MG/IPAMORELIN 6MG - LYOPHILIZED 6MG/6MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
SERMORELIN ACETATE 15MG/IPAMORELIN 15MG - LYOPHILIZED 15MG/15MG VIAL, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
Reason Lack of Sterility Assurance.
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