Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmac...
Reason: Lack of assurance of sterility.
D-0941-2022June 1, 2022Orlando, FL
Olympia Compounding Pharmacy dba Olympia Pharmacy
Class IICompleted
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; ...
Reason: Lack of assurance of sterility.
D-0927-2022June 1, 2022Orlando, FL
Olympia Compounding Pharmacy dba Olympia Pharmacy
Class IICompleted
Testosterone Cypionate 200 mg/mL in Grapeseed Oil, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0054-10
Reason: Lack of assurance of sterility.
D-0911-2022June 1, 2022Orlando, FL
Olympia Compounding Pharmacy dba Olympia Pharmacy
Class IICompleted
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceut...
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0780-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Class IITerminated
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0779-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Class IITerminated
BPC-157 2 mg/mL (5 mL) Injection, 5 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 intended to be sterile.
D-0776-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0777-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Class IITerminated
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 intended to be sterile.
D-0781-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Class IITerminated
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0775-2022April 27, 2022Richardson, TX
North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
Class IITerminated
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0778-2022April 27, 2022Richardson, TX
Vitae Enim Vitae Scientific, Inc.
Class IITerminated
PHENOBARBITAL Sodium Injection, USP, 65mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-415-25) and b) 3 x 1 mL Vials per box (NDC 42494-415-03), Rx only, Manufactured for Cameron Pharmaceutic...
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0743-2022April 13, 2022San Diego, CA
Vitae Enim Vitae Scientific, Inc.
Class IITerminated
TETRACAINE 1% Tetracaine HCI Injection, USP, 20mg/2mL (10mg/mL), 10 x 2ml Single Use Vials per box, Rx only, Manufactured for Cameron Pharmaceuticals, LLC., NDC 42494-437-10.
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0741-2022April 13, 2022San Diego, CA
Vitae Enim Vitae Scientific, Inc.
Class IITerminated
PHENOBARBITAL Sodium Injection, USP, 130 mg/mL, packaged as a) 25 x 1 mL Vials per box (NDC 42494-416-25) and b) 3 x 1mL Vials per box (NDC 42494-416-03), Rx only, Manufactured for Cameron Pharmaceuti...
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0744-2022April 13, 2022San Diego, CA
Vitae Enim Vitae Scientific, Inc.
Class IITerminated
PAPAVERINE HYDROCHLORIDE Injection, USP, 60 mg/2mL (30 mg/mL), packaged as a) 25 x 2mL Single Use Vials per box (NDC 72516-024-25) and b) 10 x 2mL Single Use Vials per box (NDC 72516-024-10); Manufact...
Reason: Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
D-0742-2022April 13, 2022San Diego, CA
Drug Depot, Inc., dba APS Pharmacy
Class IITerminated
GONADORELIN (5ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID132227, APS Pharmacy
Reason: Lack of sterility assurance.
D-0728-2022April 6, 2022Palm Harbor, FL
Drug Depot, Inc., dba APS Pharmacy
Class IITerminated
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 4 ML Formula ID 115387; b) (RM) 10 ML Formula ID 115125; APS Pharmacy
Reason: Lack of sterility assurance.
D-0730-2022April 6, 2022Palm Harbor, FL
Drug Depot, Inc., dba APS Pharmacy
Class IITerminated
(CA) GONADORELIN (4ML) 0.2 MG/ML INJECTABLE, Packaged in a multi dose 10ML vial, Formula ID136345, APS Pharmacy
Reason: Lack of sterility assurance.
D-0729-2022April 6, 2022Palm Harbor, FL
Drug Depot, Inc., dba APS Pharmacy
Class IITerminated
TESTOSTERONE CYPIONATE/ ANASTROZOLE *GS* OIL (10ML) 200MG/0.5MG/ML; Packaged in a multi dose 10ML vial, as a) (CA) 4 ML Formula ID 136164; b) (RM) 10 ML Formula ID 115962; APS Phar