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-1003-2022 | 04-13-2022 | Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 cartons/2 ml single dose vials | Class II | Terminated |
| D-1058-2022 | 04-13-2022 | Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10 Package NDCs: 0536-1047-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 bottle/1000 tablets per bottle | Class II | Terminated |
| D-1070-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0031-01), b) 25-count box (NDC 0703-0031-04), Rx only, MFG: Teva Pharma USA | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 983 cartons/1 vial each and 107 cartons/25 vials each | Class II | Terminated |
| D-1044-2022 | 04-13-2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05 Package NDCs: 61314-656-25; 61314-656-05; 61314-656-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 7 bottles | Class II | Terminated |
| D-1064-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-473-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / | Class II | Terminated |
| D-1107-2022 | 04-13-2022 | Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution, USP, sterile, 0.1%, 10 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131462810 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 44 bottles | Class II | Terminated |
| D-1090-2022 | 04-13-2022 | Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalations, Rx only, MFG: Merck Company, NDC 0085-1132-04 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 22 inhalers | Class II | Terminated |
| D-1089-2022 | 04-13-2022 | Celestone Soluspan (betamethasone sodium phosphate and betametasone acetate injectable suspension 6 mg/mL, 30 mg/5mL, multidose vial, Rx only, MFG: Merck Company, NDC 0085-4320-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 51 vials | Class II | Terminated |
| D-1078-2022 | 04-13-2022 | Propofol Injectable Emulsion, USP 200 mg per 20 mL (10 mg per mL), twenty-five 20 mL vials, Rx only, MFG: Teva Pharma USA, NDC 0591-2136-95 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 564 cartons/25 vials each | Class II | Terminated |
| D-1098-2022 | 04-13-2022 | Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 172 packs/10 per pack | Class II | Terminated |
| D-1110-2022 | 04-13-2022 | Metoprolol tablets 50 mg, 100-count botte, Rx only, MFG: Sun Pharmaceuticals, NDC 57664-0477-52 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 box | Class II | Terminated |
| D-1091-2022 | 04-13-2022 | Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL single-dose vial, Rx only, MFG: Mylan Pharma, NDC 67457-218-10 Package NDCs: 67457-218-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 9 vials | Class II | Terminated |
| D-1109-2022 | 04-13-2022 | Pilocarpine HCL Ophthalmic Solution, USP 2%, 15 mL, Rx only, MFG: Somerset Therapeutics, Inc., NDC 7006919101 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton | Class II | Terminated |
| D-1119-2022 | 04-13-2022 | Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-09 Package NDCs: 0338-0519-58; 0338-0519-09; 0338-0519-13 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 cases | Class II | Terminated |
| D-1080-2022 | 04-13-2022 | Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 27505-003-67 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 16 cartons/6 vials each | Class II | Terminated |
| D-1029-2022 | 04-13-2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 bottle | Class II | Terminated |
| D-1063-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 400 mg/10 mL (40 mg/mL), 10 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA, NDC 16714-090-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 363 vials | Class II | Terminated |
| D-1001-2022 | 04-13-2022 | Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 16 cartons/24 vials each | Class II | Terminated |
| D-1016-2022 | 04-13-2022 | Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 15 boxes | Class II | Terminated |
| D-1036-2022 | 04-13-2022 | MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15 Package NDCs: 0065-0023-15 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 8 boxes/12 vials each | Class II | Terminated |
| D-1077-2022 | 04-13-2022 | Propofol Injectable Emulsion, USP, 200 mg/ 20 mL (10 mg/mL), packaged in a) 50 mL vial, in packs of 20 (NDC 00591-2136-51), b) 100 mL vial, in packs of 10 (NDC 00591-2136-68), Rx only, MFG: Teva Pharma USA | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 31 cartons/10 & 25 vials each | Class II | Terminated |
| D-1122-2022 | 04-13-2022 | Paracentesis/Thoracentises Tray (10/cs) Rx CRFPED, Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 cases | Class II | Terminated |
| D-0996-2022 | 04-13-2022 | Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 24 bottles | Class II | Terminated |
| D-1007-2022 | 04-13-2022 | Sumatriptan Injection, USP, 6mg/0.5 mL, packaged in a box of 5 x 0.5 mL single-dose vials, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0173-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 16 single dose vials | Class II | Terminated |
| D-1121-2022 | 04-13-2022 | Biopsy and Aspiration Tray Bone Marrow Illinois 11GX4 (10/cs) Rx CRFPED Lidocaine Hydrochloride USP, 1%, 5mL, Rx only, MFG: Becton Dickinson | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 4 cases | Class II | Terminated |
| D-1092-2022 | 04-13-2022 | Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01 Package NDCs: 0378-2100-01; 0378-2100-05 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 bottle/100 capsules | Class II | Terminated |
| D-1057-2022 | 04-13-2022 | Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6461-61 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 16 cartons/100 blisters packs per carton | Class II | Terminated |
| D-0789-2022 | 04-12-2022 | Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | Preferred Pharmaceuticals, Inc. / 44 Bottles of 90 Tablets 33 Bottles of 30 Tablets | Class II | Terminated |
| D-0790-2022 | 04-12-2022 | Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Manufactured by: Eugia Pharma Specialties Limited, Hyderabad India for BluePoint Laboratories. NDC for Carton: 68001-509-60; NDC for vial: 68001-509-59 | Subpotent Drug: Out of specification for assay. | American Health Packaging / 97,975 vials | Class III | Terminated |
| D-0845-2022 | 04-12-2022 | Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), packaged in a 10 mL Multiple-Dose vial inside a carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Manufactured for: Mylan Specialty L.P., Morgantown, WV 26505, NDC 49502-393-80 | Labeling: Missing label on the vial | Mylan Pharmaceuticals Inc / 89,665 vials | Class I | Terminated |
| D-0852-2022 | 04-11-2022 | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90. Package NDCs: 13668-096-90; 13668-429-30; 13668-429-05; 13668-429-90; 13668-429-10 | CGMP deviations: tablets cracking | Torrent Pharma Inc / 24,888 bottles | Class II | Terminated |
| D-0774-2022 | 04-07-2022 | Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60 Package NDCs: 67457-445-60 | Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing. | Mylan Pharmaceuticals Inc / 33,893 vials | Class II | Terminated |
| D-0788-2022 | 04-06-2022 | Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202. | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits. | RemedyRepack Inc. / 433/30 count blister cards, 33/60 count blister cards | Class II | Terminated |
| D-0766-2022 | 04-05-2022 | Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL Vial, Rx Only, Manufactured in India, for Auromedics Pharma LLC, NDC 55150-364-01. Package NDCs: 55150-364-01; 55150-364-10; 55150-364-25 | Subpotent Drug: Out of Specification results for Assay | Aurobindo Pharma USA Inc. / 433,809 vials | Class III | Terminated |
| D-0859-2022 | 04-05-2022 | Kill 'Dat Sanitizing Products Hand Sanitizer, 1 gallon (128 fl. oz.) 80% Alcohol, OTC, Manufactured by: Lula Holdings LLC, 15532 St. Charles Avenue, New Orleans, LA, NDC 77348-001-02. | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Lula Holdings L.L.C. / 192.78 pounds | Class II | Terminated |
| D-0882-2022 | 04-05-2022 | Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA, LLC, Indianapolis, IN 46285, Box NDC 0002-8799-59, Pen NDC 002-7516-59 Package NDCs: 0002-7510-01; 0002-7510-17; 0002-7510-99; 0002-7533-01; 0002-8799-01; 0002-8799-59; 0002-8799-61; 0002-7516-01; 0002-7516-59; 0002-7516-99; 0002-7714-01; 0002-7714-59; 0002-7714-61; 0002-8213-01; 0002-8213-05; 0002-0800-01; 0002-7712-01; 0002-7712-27; 0002-7712-61; 0002-8208-01; 0002-8208-27 | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. | Cardinal Health Inc. / 1 box | Class I | Completed |
| D-0884-2022 | 04-05-2022 | Trulicity (dulaglutide) injection, 0.75 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 0002-1433-80 Package NDCs: 0002-1433-01; 0002-1433-80; 0002-1433-61; 0002-1434-01; 0002-1434-80; 0002-1434-61; 0002-2236-01; 0002-2236-80; 0002-2236-61; 0002-3182-01; 0002-3182-80; 0002-3182-61 | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions | Cardinal Health Inc. / 1 box | Class II | Completed |
| D-0883-2022 | 04-05-2022 | Trulicity (dulaglutide) injection, 1.5 mg/0.5mL once weekly, 4 Single-Dose Pens, Rx only, Eli Lilly and Company, Indianapolis, IN 46285, NDC 00002-1434-80 | TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather. | Cardinal Health Inc. / 1 box | Class II | Completed |
| D-0776-2022 | 04-05-2022 | BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 778 vials | Class II | Terminated |
| D-0777-2022 | 04-05-2022 | Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 189 vials | Class II | Terminated |
| D-0780-2022 | 04-05-2022 | PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 43 vials | Class II | Terminated |
| D-0781-2022 | 04-05-2022 | Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 76 vials | Class II | Terminated |
| D-0779-2022 | 04-05-2022 | Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 35 vials | Class II | Terminated |
| D-0778-2022 | 04-05-2022 | LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 25 vials | Class II | Terminated |
| D-0775-2022 | 04-05-2022 | ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA | Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile. | North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding / 28 vials | Class II | Terminated |
| D-0812-2022 | 04-04-2022 | QM-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0020-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1647 vials | Class II | Terminated |
| D-0828-2022 | 04-04-2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00 | Failed Reconstitution time | Olympia Compounding Pharmacy dba Olympia Pharmacy / | Class II | Terminated |
| D-0820-2022 | 04-04-2022 | T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1097 vials | Class II | Terminated |
| D-0802-2022 | 04-04-2022 | AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 310 vials | Class II | Terminated |
| D-0797-2022 | 04-04-2022 | Sermorelin Acetate, Lyophilized powder for reconstitution, Multi-Dose vials, Packaged as a) 3 mg per vial, NDC 73198-0060-00; b) 9 mg NDC 73198-0059-00, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 18060 vials | Class II | Terminated |
| D-0800-2022 | 04-04-2022 | Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 800 vials | Class II | Terminated |
| D-0811-2022 | 04-04-2022 | QM-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 150 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0019-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1679 vials | Class II | Terminated |
| D-0825-2022 | 04-04-2022 | Ultratest, Testosterone Cypionate 160 mg/mL, Testosterone Propionate 40 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0058-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1276 vials | Class II | Terminated |
| D-0808-2022 | 04-04-2022 | SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 336 vials | Class II | Terminated |
| D-0826-2022 | 04-04-2022 | Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6431 vials | Class II | Terminated |
| D-0822-2022 | 04-04-2022 | Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4521 vials | Class II | Terminated |
| D-0796-2022 | 04-04-2022 | Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF, Sterile Water for Injection USP, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. 73198-0113-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 45,935 vials | Class II | Terminated |
| D-0795-2022 | 04-04-2022 | NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution, Multi-Dose 500 mg Per Vial, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0083-00 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 16,329 vials | Class II | Terminated |
| D-0798-2022 | 04-04-2022 | QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60 mcg/mL . Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0018-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1871 vials | Class II | Terminated |
| D-0807-2022 | 04-04-2022 | SB-5, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 50 mcg/mL, 10 mL, Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0024-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1110 vials | Class II | Terminated |
| D-0816-2022 | 04-04-2022 | FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2887 vials | Class II | Terminated |
| D-0813-2022 | 04-04-2022 | RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1849 vials | Class II | Terminated |
| D-0803-2022 | 04-04-2022 | NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3509 vials | Class II | Terminated |
| D-0801-2022 | 04-04-2022 | AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10 | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1318 vials | Class II | Terminated |
| D-0814-2022 | 04-04-2022 | RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2201 vials | Class II | Terminated |
| D-0799-2022 | 04-04-2022 | T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835 . | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 6916 vials | Class II | Terminated |
| D-1149-2022 | 04-04-2022 | HAND SANITIZER SAY GOODBYE TO GERMS Alcohol Antiseptic 80% Topical Non-Sterile Solution, 12 FL OZ (254 mL) bottles, Distributed by: Hand Cleansing Gel 850 Kaliste Saloom Rd. Suite 212 Lafayette, LA 70508 UPC 8 60003 62626 9 | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Hand Sanitizer LLC / 24,020 bottles | Class II | Terminated |
| D-0815-2022 | 04-04-2022 | BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 388 vials | Class II | Terminated |
| D-0810-2022 | 04-04-2022 | ST-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 100 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0012-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2005 vials | Class II | Terminated |
| D-0806-2022 | 04-04-2022 | SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1740 vials | Class II | Terminated |
| D-0819-2022 | 04-04-2022 | PGE-3, Alprostadil 150 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0030-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 410 vials | Class II | Terminated |
| D-0827-2022 | 04-04-2022 | Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 1770 vials | Class II | Terminated |
| D-0809-2022 | 04-04-2022 | ST-1, Papaverine 30 mg/mL . Phentolamine 1.5 mg/mL . Alprostadil 50 mcg/ml, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0011-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 525 vials | Class II | Terminated |
| D-0817-2022 | 04-04-2022 | PGE-1, Alprostadil 40 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0028-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 821 vials | Class II | Terminated |
| D-0823-2022 | 04-04-2022 | Testosterone Cypionate 200 mg/mL (in Grapeseed Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0054-10; b) 5 mL Multi-Dose vial, NDC 73198-0054-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 7161 vials | Class II | Terminated |
| D-0818-2022 | 04-04-2022 | PGE-2, Alprostadil 80 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0029-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 460 vials | Class II | Terminated |
| D-0805-2022 | 04-04-2022 | T-101, Papaverine 17.65 mg/mL . Phentolamine 0.59 mg/mL . Alprostadil 5.9 mcg/mL. Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0014-10; b) 5 mL Multi-Dose vial, NDC 73198-0014-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 2437 vials | Class II | Terminated |
| D-0824-2022 | 04-04-2022 | Testosterone Cypionate 200 mg/mL, (in Sesame Oil), Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0055-10; b) 5 mL Multi-Dose vial, NDC 73198-0055-05, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 3962 vials | Class II | Terminated |
| D-0821-2022 | 04-04-2022 | Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 257 vials | Class II | Terminated |
| D-0804-2022 | 04-04-2022 | T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC: 73198-0013-10; b) 5 mL Multi-Dose vial, NDC 73198-0013-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. | CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated | Olympia Compounding Pharmacy dba Olympia Pharmacy / 4129 vials | Class II | Terminated |
| D-0748-2022 | 04-01-2022 | Travoprost Ophthalmic Solution, USP, 0.004%, 2.5 mL bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-9651-32. Package NDCs: 0378-9651-32; 0378-9651-50 | Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing. | Mylan Pharmaceuticals Inc / 20,112 bottles | Class II | Terminated |
| D-0752-2022 | 04-01-2022 | Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-001-06 | Subpotent | Jubilant Cadista Pharmaceuticals, Inc. / 19,222 Bottles (100-count) | Class III | Terminated |
| D-0770-2022 | 04-01-2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 single-use vials (0.25 mL each) per box, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, ZI de la Guerie, F-50211 Coutances Cedex, France, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 47335-506-96 Package NDCs: 47335-506-96; 47335-507-97 | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter. | SUN PHARMACEUTICAL INDUSTRIES INC / 73,030 boxes | Class III | Terminated |
| D-0541-2023 | 04-01-2022 | CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx | Marketed Without an Approved NDA/ANDA | Wellness BioSciences / 2000 inhalers | Class II | Ongoing |
| D-0861-2022 | 04-01-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16 | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 885 cartons | Class II | Terminated |
| D-0860-2022 | 04-01-2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16 | Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point. | Mylan Institutional, Inc. (d.b.a. UDL Laboratories) / 555 cartons | Class II | Terminated |
| D-0745-2022 | 04-01-2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefilled syring, Rx Only, RITEDOSE, 503B Outsourcing Facility, A Division of the RITEDOSE Corporation, 1 Technology Circle, Columbia, SC 29203, 1-866-994-4670, NDC: 65302-509-30, barcode N (01) 003 65302 50930 0 | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL. | The Ritedose Corporation / 3795 syringes | Class III | Terminated |
| D-0746-2022 | 03-31-2022 | Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03) Package NDCs: 0006-0575-82; 0006-0575-61; 0006-0575-62; 0006-0575-01; 0006-0575-52; 0006-0575-56; 0006-0575-02; 0006-0575-03; 0006-0577-61; 0006-0577-62; 0006-0577-82; 0006-0577-01; 0006-0577-52; 0006-0577-56; 0006-0577-02; 0006-0577-03 | Presence of foreign substance: Presence of stainless steel particulates in tablets. | MERCK SHARP & DOHME CORP / 3600 cartons | Class II | Terminated |
| D-0843-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 2,361,924 bottles | Class II | Terminated |
| D-0842-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 303,696 bottles | Class II | Terminated |
| D-0841-2022 | 03-31-2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-215-09; 68180-215-03; 68180-215-01; 68180-215-06; 68180-216-06; 68180-216-09; 68180-216-01; 68180-216-03; 68180-217-06; 68180-217-09; 68180-217-01; 68180-217-03 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,214,016 bottles | Class II | Terminated |
| D-0840-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,247,067 bottles | Class II | Terminated |
| D-0838-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 657,336 bottles | Class II | Terminated |
| D-0839-2022 | 03-31-2022 | Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA. Package NDCs: 68180-210-09; 68180-210-03; 68180-210-01; 68180-210-06; 68180-211-06; 68180-211-09; 68180-211-03; 68180-211-01; 68180-212-06; 68180-212-03; 68180-212-09; 68180-212-01; 68180-376-03; 68180-376-06; 68180-376-01; 68180-376-09; 68180-377-03; 68180-377-01; 68180-377-09; 68180-377-06; 68180-378-09; 68180-378-03; 68180-378-06; 68180-378-01; 68180-307-01; 68180-307-02; 68180-307-09; 68180-307-06; 68180-308-06; 68180-308-09; 68180-308-02; 68180-308-01; 68180-309-06; 68180-309-09; 68180-309-02; 68180-309-01 | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Lupin Pharmaceuticals Inc. / 1,466,150 bottles | Class II | Terminated |
| D-0211-2024 | 03-30-2022 | Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | Unilever United States Inc. / unknown | Class II | Ongoing |
| D-0210-2024 | 03-30-2022 | Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611 | Chemical contamination: presence of benzene | Unilever United States Inc. / unknown | Class I | Ongoing |
| D-0787-2022 | 03-29-2022 | Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0324-28. | Incorrect/Undeclared Excipient: Product contains alcohol | AptaPharma Inc. / 40000 - 50000 units | Class III | Terminated |
| D-0785-2022 | 03-29-2022 | Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6. | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug. | Pink Toyz / 120 blister cards | Class I | Terminated |
| D-0876-2022 | 03-29-2022 | Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02 | Chemical Contamination; FDA analysis found product to contain methanol | Best Brands Consumer Products, Inc. / 44,640 bottles | Class I | Terminated |
| D-0877-2022 | 03-29-2022 | The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02 | Chemical Contamination; FDA analysis found product to contain benzene | Best Brands Consumer Products, Inc. / 346,320 bottles | Class I | Terminated |
