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 October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0052-2020 | 09-12-2019 | Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676632 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1980 vials | Class II | Terminated |
| D-0042-2020 | 09-12-2019 | Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674177 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6568 vials | Class II | Terminated |
| D-0095-2020 | 09-12-2019 | Sermorelin, 3 mg/GHRP6, 3 mg/GHRP2, 3 mg/Vial, For SC Use, Vial-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673816 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 647 vials | Class II | Terminated |
| D-0097-2020 | 09-12-2019 | Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 152 cartridges | Class II | Terminated |
| D-0113-2020 | 09-12-2019 | Vitamin 9 Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674147 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 470 vials | Class II | Terminated |
| D-0096-2020 | 09-12-2019 | Sermorelin 9 mg / GHRP6, 5.4 mg / GHRP2, 5.4 mg, Vial For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673589 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 246 vials | Class II | Terminated |
| D-0051-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 2,500 mcg/100 mL (25 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 33216286000 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1882 bags | Class II | Terminated |
| D-0098-2020 | 09-12-2019 | Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321601122 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 64 vials | Class II | Terminated |
| D-0041-2020 | 09-12-2019 | Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Use-Contains Sulfites, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675033 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 602 vials | Class II | Terminated |
| D-0063-2020 | 09-12-2019 | Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678334 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 345 vials | Class II | Terminated |
| D-0110-2020 | 09-12-2019 | Vitamin 10 B Lyophilized, Vial, For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678338 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6747 vials | Class II | Terminated |
| D-0071-2020 | 09-12-2019 | LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL (PF) Ophthalmic Injection, 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678362 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2255 syringes | Class II | Terminated |
| D-0039-2020 | 09-12-2019 | Alpha Lipoic Acid (PF) 750 mg/30 mL (25 mg/mL) 30 mL Single Dose Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674205 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 77 vials | Class II | Terminated |
| D-0111-2020 | 09-12-2019 | Vitamin 10 D Lyophilized, Vial For IM/Slow IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678341 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 508 vials | Class II | Terminated |
| D-0053-2020 | 09-12-2019 | Glutathione 30 mL Vial-For IM Use-Hypertonic solution, 6,000 mg/30 mL (200 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321674186 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 402 vials | Class II | Terminated |
| D-0090-2020 | 09-12-2019 | Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677749 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 317 vials | Class II | Terminated |
| D-0043-2020 | 09-12-2019 | Bimix #3 (Papaverine HCl 30 mg/mL/Phentolamine Mesylate 3 mg/mL) in 5 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676500 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 162 vials | Class II | Terminated |
| D-0001-2020 | 09-12-2019 | ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by: Greenstone LLC Peapack, NJ 07977 Made in Netherlands. NDC 59762-2250-2 | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. | Pfizer Inc. / 7,824 100-count bottles | Class III | Terminated |
| D-0002-2020 | 09-12-2019 | Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made in Netherlands Distributed by Parke-Davis Division of Pfizer In NY, NY 10017, NDC 0071-0237-24 Package NDCs: 0071-0237-24 | Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020. | Pfizer Inc. / 7,686 100-count bottles | Class III | Terminated |
| D-1863-2019 | 09-09-2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59 | Failed Impurities/Degradation Specificattion | West-Ward Columbus Inc / 32,347 bottles | Class II | Terminated |
| D-0131-2020 | 09-06-2019 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30 | GMP Deviation: lot not intended for commercial distribution. | Teva Pharmaceuticals USA / 5,849 bottles | Class III | Terminated |
| D-1862-2019 | 09-06-2019 | Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920, NDC 13668-453-01. Package NDCs: 13668-453-30; 13668-453-01; 13668-462-30; 13668-462-01 | Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing. | Torrent Pharma Inc. / 2472 bottles | Class II | Terminated |
| D-1852-2019 | 09-06-2019 | Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03 Package NDCs: 0409-3977-01; 0409-3977-03; 0409-1093-14; 0409-1093-04 | Lack of Assurance of Sterility | Pfizer Inc. / 185,700 vials | Class II | Terminated |
| D-1876-2019 | 09-06-2019 | Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For subcutaneous use only, Rx Only, Manufactured by GlaxoSmithKline LLC, Philadelphia, PA 19112, Distributed by GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0173-0892-42. Package NDCs: 0173-0881-01; 0173-0881-61; 0173-0892-01; 0173-0892-42; 0173-0892-61; 0173-0892-63; 0173-0904-42 | Temperature Abuse; Product stored and shipped outside of labeled storage requirements. | Cardinal Health dba Specialty Pharmaceutical Services / 38 syringes | Class II | Terminated |
| D-0125-2020 | 09-06-2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g NDC# 71052-530-05; b) 50 g NDC# 71052-530-55, c) 25g NDC# 71052-530-25, Darmerica LLC 198 Wilshire Blvd Casselberry, FL 32707 | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin. | Darmerica, LLC / 1.8 kilograms | Class I | Terminated |
| D-1848-2019 | 09-06-2019 | Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. Made in India. NDC: 0378-5431-35 | Failed Impurities/Degradation Specifications:OOS for unknown impurity. | Mylan Pharmaceuticals Inc. / 13,157 5 mL bottles | Class III | Terminated |
| D-0145-2020 | 09-04-2019 | Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90 | CGMP Deviation: Presence of dark brown discoloration on edges of tablets. | Jubilant Cadista Pharmaceuticals, Inc. / 63,216 bottles | Class II | Terminated |
| D-1855-2019 | 09-03-2019 | 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles | Lack of Processing Controls: | Compounded Solutions in Pharmacy / a) 4x5 ml, b) 1x10 ml bottles | Class II | Terminated |
| D-1854-2019 | 09-03-2019 | 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles | Lack of Processing Controls: | Compounded Solutions in Pharmacy / a) 6x5ml b) 4x10 c) 1x15 ml bottles, | Class II | Terminated |
| D-1853-2019 | 09-03-2019 | 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. | Lack of Processing Controls: | Compounded Solutions in Pharmacy / 3x3 ml dropper bottles | Class II | Terminated |
| D-0587-2020 | 09-03-2019 | Fentanyl Citrate and Bupivacaine 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-0606-2020 | 09-03-2019 | Hydromorphone HCL and Bupivacaine HCL and Baclofen 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-0599-2020 | 09-03-2019 | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, 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-0586-2020 | 09-03-2019 | 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-0584-2020 | 09-03-2019 | Bupivacaine HCL and Clonidine HCL and Hydromorphone 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-0601-2020 | 09-03-2019 | Morphine Sulfate and Bupivacaine 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-0588-2020 | 09-03-2019 | 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-0595-2020 | 09-03-2019 | 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-0607-2020 | 09-03-2019 | Hydromorphone HCL and Bupivacaine 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-0602-2020 | 09-03-2019 | Baclofen and 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-0580-2020 | 09-03-2019 | Clonidine HCL/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-0605-2020 | 09-03-2019 | Fentanyl Citrate and Clonidine HCL and Morphine Sulfate 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-0208-2020 | 08-12-2019 | S-CALM INJECTION, (MAG S04/GABAPENTIN/TAURINE/THEANINE 50/50/50/50MG/ML) MDV, 10 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-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-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-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-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-0254-2020 | 08-12-2019 | S-TRIMIX (15MG/0.5MG/10MCG/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 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-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-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-0287-2020 | 08-12-2019 | S-TEST CYP/NAN-DECA 200/50MG/ML MDV 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 / 3x10 ml glass vials | 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 |
