Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0608-2020 | 09-03-2019 | Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0604-2020 | 09-03-2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0600-2020 | 09-03-2019 | Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363 | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0589-2020 | 09-03-2019 | Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0594-2020 | 09-03-2019 | Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0590-2020 | 09-03-2019 | Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0583-2020 | 09-03-2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0585-2020 | 09-03-2019 | Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0596-2020 | 09-03-2019 | Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0578-2020 | 09-03-2019 | Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0597-2020 | 09-03-2019 | Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0591-2020 | 09-03-2019 | Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0581-2020 | 09-03-2019 | Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0593-2020 | 09-03-2019 | Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0579-2020 | 09-03-2019 | Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / 17 vials | Class II | Terminated |
| D-0603-2020 | 09-03-2019 | Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0582-2020 | 09-03-2019 | Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0592-2020 | 09-03-2019 | Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634. | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-0598-2020 | 09-03-2019 | Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363 | Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. | Coast Quality Pharmacy, LLC dba Anazao Health / Unknown | Class II | Terminated |
| D-1849-2019 | 08-30-2019 | Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy / | Class II | Terminated |
| D-1850-2019 | 08-30-2019 | Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 | Lack of assurance of sterility. | Pacifico National, Inc. dba AmEx Pharmacy / | Class II | Terminated |
| D-1879-2019 | 08-30-2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73. | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count. | Plastikon Healthcare LLC / 1,433 cases | Class I | Terminated |
| D-1880-2019 | 08-29-2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001. | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. / 52882.23 grams | Class II | Terminated |
| D-1877-2019 | 08-29-2019 | Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09 | Failed Impurities/Degradation Specifications | Preferred Pharmaceuticals, Inc / 79 (90 ct.) bottles | Class II | Terminated |
| D-1882-2019 | 08-29-2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001, NDC 49821-0075-XX | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. / 316703.32 | Class II | Terminated |
| D-1881-2019 | 08-29-2019 | Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Materials 2003 Nolte Drive, West Deptford, NJ 08066-1742 (856) 384-7001 | cGMP Deviations: Potential glass contamination | Johnson Matthey Inc. / 26625 grams | Class II | Terminated |
| D-1875-2019 | 08-28-2019 | AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50. | Failed Stability Specifications. | AVKARE Inc. / 5953 bottles | Class II | Terminated |
| D-0144-2020 | 08-28-2019 | Ascorbic Acid Sterile Injection Solution, 500 mg/mL, 50 mL vial, Non-Corn Source, Rx only, Atlas Pharmaceuticals, LLC, 711 E Carefree Hwy, Suite 107, Phoenix, AZ 85085, NDC 71591-500-50. | Labeling: Not Elsewhere Classified; product is labeled as "Non-Corn Source" however the product is from a corn source. | Atlas Pharmaceuticals, LLC / 1646 vials | Class II | Terminated |
| D-1847-2019 | 08-27-2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687-362-11), Distributed by American Health Packaging, Columbus, OH | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets. | American Health Packaging / 60 cartons | Class III | Terminated |
| D-0120-2020 | 08-26-2019 | minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05. | Failed Dissolution Specifications: | EPI Health, LLC / 1,626 5-count bottles | Class III | Terminated |
| D-0800-2020 | 08-24-2019 | Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302 | Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs) | Tuscano and Delucia Group (DBA Entropic Labs) / 60 | Class II | Terminated |
| D-1868-2019 | 08-23-2019 | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton (NDC 70677-0008-1), sunmark, Distributed by McKesson, One Post Street, San Francisco, CA 94104. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / a) 11,928 cartons; b) 288 cartons | Class II | Terminated |
| D-1867-2019 | 08-23-2019 | fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bentonville, AR 22716, NDC 68196-976-91, UPC 0 78742 23550 9. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 71,748 bottles | Class II | Terminated |
| D-1871-2019 | 08-23-2019 | Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648; Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 6104 bottles | Class II | Terminated |
| D-1866-2019 | 08-23-2019 | Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA 19087, NDC 46122-387-23. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 3240 cartons | Class II | Terminated |
| D-1873-2019 | 08-23-2019 | Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0097-55. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 4920 cartons | Class II | Terminated |
| D-1865-2019 | 08-23-2019 | Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b) 30-count cartons (NDC 60000-409-30); c) 45-count bonus cartons (NDC 60000-409-48); d) 45-count cartons (NDC 60000-409-45); CAREone, Distributed by: Foodhold U.S.A., LLC, Landover, MD 20785. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / a) 9662 cartons; b) 7382 cartons; c) 5184 cartons; d) 9842 cartons | Class II | Terminated |
| D-1864-2019 | 08-23-2019 | Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike, Lawrenceville, NJ 08648, NDC 58602-711-21 | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 8,240 bottles | Class II | Terminated |
| D-1874-2019 | 08-23-2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256, NDC 53943-021-09. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 4536 cartons | Class II | Terminated |
| D-1870-2019 | 08-23-2019 | Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cartons (NDC 62011-0315-2) HealthMart PHARMACY, Distributed by McKesson, One Post Street, San Francisco, CA 94104. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / a) 10,992 cartons; b) 24,792 cartons | Class II | Terminated |
| D-1872-2019 | 08-23-2019 | Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswick Pike, Lawrenceville, NJ 08648; NDC 58602-820-09. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 240 bottles | Class II | Terminated |
| D-1869-2019 | 08-23-2019 | Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-995-62. | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 129,600 cartons | Class II | Terminated |
| D-1851-2019 | 08-21-2019 | Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10 Package NDCs: 33342-031-10; 33342-031-15; 33342-031-06; 33342-031-12; 33342-032-10; 33342-032-15; 33342-032-06; 33342-032-12; 33342-033-10; 33342-033-15; 33342-033-06; 33342-033-12; 33342-034-10; 33342-034-15; 33342-034-06; 33342-034-12; 33342-035-10; 33342-035-15; 33342-035-06; 33342-035-12 | Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg | Macleods Pharma Usa Inc / 1837 90-count bottles | Class III | Terminated |
| D-1843-2019 | 08-16-2019 | Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09. | Lack of Assurance of Sterility. | SCA Pharmaceuticals, LLC / 922 syringes | Class II | Terminated |
| D-1845-2019 | 08-14-2019 | RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017. | Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. | Pfizer Inc. / a) 20,117 cartons; b) 2,502 cartons | Class II | Terminated |
| D-0210-2020 | 08-12-2019 | S-DEXTROSE/GLYCERIN/PHENOL 25/25/2.5% INJ SOLN, 30 ml glass vial, Rx Only, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 8x30 ml glass vial | Class II | Terminated |
| D-0212-2020 | 08-12-2019 | S-DEXTROSE 50% MDV SOLN, 50 ML glass vial, RX Only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 5x50 ml glass vial | Class II | Terminated |
| D-0230-2020 | 08-12-2019 | S-HYDROXOCOBALAMIN 10MG/ML MDV INJ SOL, 30 ML glass vial, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 glass vials | Class II | Terminated |
| D-0227-2020 | 08-12-2019 | S-HYALURONIDASE 150U/ML INJ SOLN (PF), 5 ML vial, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x5 ml vials | Class II | Terminated |
| D-0258-2020 | 08-12-2019 | S-ZINC SULFATE !MG/ML MDV SOLN, Rx only, 10ml glass vial. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 22x10 ml glass vial | Class II | Terminated |
| D-0247-2020 | 08-12-2019 | S-PYRIDOXINE HCL (B6) 100MG/ML MDV, Rx Only, 30ml glass vial. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 38x30 ml glass vials | Class II | Terminated |
| D-0294-2020 | 08-12-2019 | S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml glass vial | Class II | Terminated |
| D-0270-2020 | 08-12-2019 | S-LIDOCAINE HCL 2% MDV INJ SOLN, packaged in 50ML vial, Red Mountain Compounding Rx, | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 6 vials | Class II | Terminated |
| D-0290-2020 | 08-12-2019 | S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x 10ml and 13 ml glass vials | Class II | Terminated |
| D-0293-2020 | 08-12-2019 | S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 46 x30 ML glass vials | Class II | Terminated |
| D-0205-2020 | 08-12-2019 | S-BENZALKONIUM CHLORIDE 0.013% SOLUTION, 1000ml plastic container, For irrigation use only, Rx only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 4x1000 plastic containers | Class II | Terminated |
| D-0229-2020 | 08-12-2019 | S-HYDROGEN PEROXIDE 3% (PF) 30ML glass vial, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml glass vials | Class II | Terminated |
| D-0273-2020 | 08-12-2019 | S-METHYLCOBALAMIN 5,000MCG/ML MDV Injection, 30 ML glass vial, Rx Only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 28x30 ml glass vials | Class II | Terminated |
| D-0291-2020 | 08-12-2019 | S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x10 ml glass vials | Class II | Terminated |
| D-0259-2020 | 08-12-2019 | S-CALCIUM GLUCONATE 1% OPTH IRRIGATION, 50ML plastic container, RX Only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x50 ml plastic container | Class II | Terminated |
| D-0246-2020 | 08-12-2019 | S-PROGESTERONE/TESTOSTERONE 0.05%/0.03% OIL OPTH, Rx Only 10ml dropper bottle, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10ml droptainer | Class II | Terminated |
| D-0295-2020 | 08-12-2019 | S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5 ml glass vial | Class II | Terminated |
| D-0284-2020 | 08-12-2019 | S-TEST CYP 50MG/ML MDV IN ETHYL OLEATE OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml glass vial | Class II | Terminated |
| D-0228-2020 | 08-12-2019 | S-HYDROCHLORIC ACID 2MG/ML INJ SOLN, 50 ML glass vial, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0265-2020 | 08-12-2019 | S-HCG 3000 U/ML MDV SOLN, 10 ML glass vials, Rx Only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 8x10 ML vials | Class II | Terminated |
| D-0216-2020 | 08-12-2019 | S-E2/TEST CYP 1MG/4MG SESAME OIL INJECTION, 10 ml glass vial, Rx Only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x10 ml glass vials | Class II | Terminated |
| D-0233-2020 | 08-12-2019 | S-LIDOCAINE HCL 2% INHALATION SOLN SYRINGES, 2ML syringe, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x2ML syringe | Class II | Terminated |
| D-0206-2020 | 08-12-2019 | S-CALCIUM CHLORIDE 100MG/ML (PF) INJ SOLN, 10ml glass vial, Rx only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 glass vial | Class II | Terminated |
| D-0285-2020 | 08-12-2019 | S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 559 x 5, 10, 13 ml glass vials | Class II | Terminated |
| D-0255-2020 | 08-12-2019 | S-VIT B COMPLEX (1/3/5/6/12A) MDV INJ 100/2/2/100/1MG/ML, 30 ML glass vial. Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml glass vials | Class II | Terminated |
| D-0283-2020 | 08-12-2019 | S-TEST CYP 25MG/ML IN SESAME OIL, Rx Only, 5ml glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5 ml glass vial | Class II | Terminated |
| D-0207-2020 | 08-12-2019 | S-CALCIUM GLUCONATE 10% INJECTION (PF), packaged in a) 10 ml b) 5ml glass vials, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 18x10 ml and 1x5 ml glass vials | Class II | Terminated |
| D-0279-2020 | 08-12-2019 | S-PROCAINE HCL 2% BUFFERED, Rx Only, a) PFV-single dose 10ml b)MDV 30ml glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0238-2020 | 08-12-2019 | S-MAGNESIUM SULFATE 500MG/ML (4MEQ/ML) MDV INJ SOLN, 30 ML vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml vials | Class II | Terminated |
| D-0288-2020 | 08-12-2019 | S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 4x 10ml and 13 ml glass vials | Class II | Terminated |
| D-0202-2020 | 08-12-2019 | S-ATROPINE 0.02% OPTHALMIC SOLUTION, 10 ML dropper bottle, RX only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x10 ml dropper bottles | Class II | Terminated |
| D-0292-2020 | 08-12-2019 | S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 10x10 ml glass vial | Class II | Terminated |
| D-0289-2020 | 08-12-2019 | S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 ml glass vials | Class II | Terminated |
| D-0256-2020 | 08-12-2019 | S-VIT A PALMITATE 50,000 IU/ML CORN OIL, Rx Only, 10ml dropper bottle. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1 vial | Class II | Terminated |
| D-0261-2020 | 08-12-2019 | S-EDETATE DISODIUM 15% INJ, packaged in 50ml glass vial, Rx Only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 10 50 ml vials | Class II | Terminated |
| D-0209-2020 | 08-12-2019 | S-CYANOCOBALAMIN 1,000 MCG/ML MDV INJ SOLN, packaged in a) 10ml and b) 30 ml glass vial, Rx Only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 5x10 ml and 5x30 ml glass vials | Class II | Terminated |
| D-0264-2020 | 08-12-2019 | S-FOLIC ACID 20MG/ML MDV INJ, packaged in a)10ml b) 30ml, glass vials, Rx Only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10, 1x30 ml glass vials | Class II | Terminated |
| D-0200-2020 | 08-12-2019 | S-ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, 10ML dropper bottle, RX only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x 10 ml bottles | Class II | Terminated |
| D-0242-2020 | 08-12-2019 | S-NANDROLONE DEC 200MG/ML MDV INJ in SESAME OIL, Rx Only, 10ml glass vial. Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10ml glass vial | Class II | Terminated |
| D-0231-2020 | 08-12-2019 | S-HYDROXYPROG CAPROATE 250MG/ML IN SESAME OIL INJ, 5ML glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5 ml vial | Class II | Terminated |
| D-0263-2020 | 08-12-2019 | S-ESTRADIOL VALERATE 40MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2 5ml and 10 ml glass vials | Class II | Terminated |
| D-0274-2020 | 08-12-2019 | S-MIC/B12(C)/CARNITINE 25/50/50/1/50MG/ML MDV INJ; Lot #: S07172019DT@10, Exp 1/17/20; S02142019DH@01, Exp 8/14/19; S03192019DT@04,Exp 9/19/19; " S04162019DT@15, Exp 10/16/19; S07232019DH@04, Exp 1/23/20; S02142019DH@01, Exp 8/14/19; S04162019DT@15, Exp 9/9/19; s07092019dt@19, Exp 8/9/19; S07292019DH@09, Exp 8/29/19; S02192019DH@10, Exp 8/19/19; S03302019DT@02, Exp 9/30/19; S05062019DH@12, Exp 11/6/19; S06162019DH@13, Exp 12/16/19; S07102019DT@16, Exp 1/10/20; S07132019DT@05, Exp 1/13/20; S01302019DT@08, Exp 8/30/19; S03072019DH@01, Exp 9/7/19; S02192019DH@12, Exp 8/19/19; S03072019DH@02, Exp 9/7/19; S03272019DT@04, Exp 9/27/19; S04172019DT@03, Exp 10/17/19; S04302019DT@11, Exp 10/30/19; S05162019DH@20, Exp 11/16/19; S05292019DT@03, Exp 11/29/19; S06252019DH@17, Exp 12/25/19; S07172019DT@12, Exp 1/17/20; S07182019DT@08, Exp 1/18/20; S05242019DT@10, Exp 11/24/19 Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / N/A | Class II | Terminated |
| D-0272-2020 | 08-12-2019 | S-METHYLCOBALAMIN 25MG/ML MDV INJ; 10ML glass vial, Rx Only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x30 ml glass vials | Class II | Terminated |
| D-0224-2020 | 08-12-2019 | S-GLUTATHIONE 200MG/ML MDV, packaged in a) 12 ML b) 30 ml, glass vial, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x12 ML and 79x30 ML vials | Class II | Terminated |
| D-0240-2020 | 08-12-2019 | S-METHYLCOBALAMIN 1,000MCG/ML MDV INJ; a) 10ml, b) 30 ml glass vial, Rx Only, Red mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 60x 10 and 30 ML glass vials | Class II | Terminated |
| D-0203-2020 | 08-12-2019 | S-ATROPINE 0.5% OPTH SOLN, 10 ML dropper bottle, RX only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x10 ml dropper bottle | Class II | Terminated |
| D-0198-2020 | 08-12-2019 | S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2 x 30 mL vials | Class II | Terminated |
| D-0296-2020 | 08-12-2019 | S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x5ml glass vial | Class II | Terminated |
| D-0262-2020 | 08-12-2019 | S-ESTRADIOL CYP 5MG/ML MDV INJ IN SESAME OIL, packaged in a) 5ml, b) 10ml, c) 11ml, glass vials, Rx Only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml, 7x10ml, 3x11ml, glass vials | Class II | Terminated |
| D-0282-2020 | 08-12-2019 | S-TEST CYP 25MG/ML IN ETHYL OLEATE OIL MDV, Rx Only, a)5 ml b) 10 ml c) 13 ml glass vial, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 91 x 5, 10, 13 ML glass vials | Class II | Terminated |
| D-0217-2020 | 08-12-2019 | S-EDETATE CALCIUM 300MG/ML INJ SOLN, packaged in a) 50ml and b) 100ML glass vial, Rx Only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 3x50ml, 6x100ml glass vials | Class II | Terminated |
| D-0219-2020 | 08-12-2019 | S-ESTRADIOL VALERATE 20MG/ML MDV INJ IN ETHYL OLEATE, packaged in a) 5ml, b) 10ml, glass vial, RX Only, Red Mountain Compounding RX. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 2x5ml, 1x10 ml glass vials | Class II | Terminated |
| D-0234-2020 | 08-12-2019 | S-LIDOCAINE HCL 1% MDV SOLN, 50ML Vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 13x50 ml vials | Class II | Terminated |
| D-0267-2020 | 08-12-2019 | S-HYDROXOCOBA 5000MCG/ML INJ, 30ML glass vial, Red Mountain Compounding Rx | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x30 Ml glass vial | Class II | Terminated |
| D-0280-2020 | 08-12-2019 | S-TESTOSTERONE CYP 100MG/ML in SESAME OIL, 5ml Rx only, Red Mountain Compounding Rx. | Lack of Assurance of Sterility | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy / 1x5ml glass vial | Class II | Terminated |
