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-1111-2022 | 04-13-2022 | Sumatriptan Succinate Tablets, 100 mg, 9 (1 x 9) Unit-of- use tablets box, Rx only, MFG: Sun Pharmaceuticals, NDC 62756-522-69 Package NDCs: 62756-520-83; 62756-520-88; 62756-520-08; 62756-520-18; 62756-520-69; 62756-520-93; 62756-520-01; 62756-521-83; 62756-521-88; 62756-521-08; 62756-521-18; 62756-521-69; 62756-521-93; 62756-521-01; 62756-522-83; 62756-522-88; 62756-522-08; 62756-522-18; 62756-522-69; 62756-522-93; 62756-522-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/9 blister packs | Class II | Terminated |
| D-1058-2022 | 04-13-2022 | Sodium Bicarbonate Tablets, 600 mg, 1000-count bottle, MFG: Major Pharma, NDC 0536-1047-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 bottle/1000 tablets per bottle | Class II | Terminated |
| D-1095-2022 | 04-13-2022 | Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx only, MFG: Pfizer, NDC 0409-1163-01 Package NDCs: 0409-1159-18; 0409-1159-01; 0409-1159-19; 0409-1159-02; 0409-1160-18; 0409-1160-01; 0409-1162-18; 0409-1162-01; 0409-1162-19; 0409-1162-02; 0409-1163-18; 0409-1163-01; 0409-1165-18; 0409-1165-01; 0409-1165-19; 0409-1165-02; 0409-9043-11; 0409-9043-01; 0409-9046-11; 0409-9046-01; 0409-9045-11; 0409-9045-01; 0409-9045-16; 0409-9045-17; 0409-9042-11; 0409-9042-01; 0409-9042-16; 0409-9042-17 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 30 vials | Class II | Terminated |
| D-1052-2022 | 04-13-2022 | Xylocaine + Epinephrine, multi dose vial 1%, packaged in a) 20 mL, 25-count box (NDC 63323-482-27) b) 50 mL, 25-count box (NDC 63323-482-57), Rx only, MFG: Fresenius Kabi USA LLC Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 76 trays/25 vials per tray | Class II | Terminated |
| D-1043-2022 | 04-13-2022 | Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 3 cartons/30 pouches per carton | Class II | Terminated |
| D-1084-2022 | 04-13-2022 | E-Z-HD (Barium Sulfate for Oral Suspension), 98% w/w, 340 g bottle, Rx only, MFG: Bracco Diagnostics Inc., NDC 32909-764-01 Package NDCs: 32909-764-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 19 cases | Class II | Terminated |
| D-1081-2022 | 04-13-2022 | Revonto (dantrolene sodium for injection), 20 mg/vial, 6-count box, Rx only, MFG: US WorldMeds, Inc., NDC 78670-003-67 Package NDCs: 78670-003-67 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 49 cartons/6 vials each | Class II | Terminated |
| D-1017-2022 | 04-13-2022 | GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 187 vials | Class II | Terminated |
| D-1076-2022 | 04-13-2022 | Proair, HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 59310-579-22 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 56 inhalers | Class II | Terminated |
| D-1060-2022 | 04-13-2022 | Medroxyprogesterone acetate injectable suspension, 150 mg/mL, 1 mL single dose vial, Rx only, MFG: NorthStarRx/Teva Pharma USA , NDC 16714-981-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 780 vials | Class II | Terminated |
| D-1056-2022 | 04-13-2022 | Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-1453-61 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 3 boxes/100 blisters per box | Class II | Terminated |
| D-1008-2022 | 04-13-2022 | Betadine 5%, Sterile Ophthalmic Prep Solution, (povidine-iodine ophthalmic solution), 1 fl. oz. (30 mL), Rx only, Mfd for: Alcon Surgical Inc., NDC 0065-0411-30 Package NDCs: 0065-0411-30 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 799 cartons/1 bottle each | Class II | Terminated |
| D-1101-2022 | 04-13-2022 | Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL unit dose cups (NDC 0121-0978-10), b) 100-count box (NDC 0121-0978-00), Rx only, MFG: Pharmaceutical Associates Inc. Package NDCs: 0121-0489-05; 0121-0489-00; 0121-0978-10; 0121-0978-00 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 case/100 unit dose cups | Class II | Terminated |
| D-1071-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200mg/5mL (40 mg/mL), 5 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0043-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 65 cartons/1 vial each | Class II | Terminated |
| D-1035-2022 | 04-13-2022 | Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 Package NDCs: 0065-0303-55 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 13 bottles | Class II | Terminated |
| D-1073-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL single dose vial (NDC 0703-0051-01) b) 25-count box (NDC 0703-0051-04), Rx only, MFG: Teva Pharma USA | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1088 cartons/1 vial each and 63 cartons/25 vials each | Class II | Terminated |
| D-1050-2022 | 04-13-2022 | Xylocaine - MPF (lidocaine HCl and epinephrine injection, USP), 1%, 300 mg/30 mL, single dose vial, 5-count box, Rx only, MFG: App Pharmaceuticals LLC, NDC 63323-0487-31 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 vial | Class II | Terminated |
| D-1074-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/5mL (80 mg/mL), 5 mL multi-dose vials, Rx only, MFG: Teva Pharma USA, NDC 0703-0063-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 816 cartons/1 vial each | Class II | Terminated |
| D-1062-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension, USP, 200 mg/5 mL (40 mg/mL), 5 mL Multiple Dose Vial, Rx only, MFG: NorthstarRx/Teva Pharma USA , NDC 16714-089-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 263 vials | Class II | Terminated |
| D-1086-2022 | 04-13-2022 | Gastrografin (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP), packaged in: Twenty-four 30 mL single dose bottles, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0445-35 Package NDCs: 0270-0445-35; 0270-0445-40 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 case | Class II | Terminated |
| D-0999-2022 | 04-13-2022 | Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 4 cartons/25 vials each | 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-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-1023-2022 | 04-13-2022 | Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 aerosols | 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-1113-2022 | 04-13-2022 | Tetracaine Hydrochloride Ophthalmic Solution, 0.5%, 4 mL bottle, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0741-14 Package NDCs: 0065-0741-12; 0065-0741-14 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 43 cartons/12 blister packs | 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-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-1004-2022 | 04-13-2022 | Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/30 patches | Class II | Terminated |
| D-1066-2022 | 04-13-2022 | Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottle, Rx only, MFG: Teva/Actavis, NDC 00228-2127-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 63 bottles/100 count | Class II | Terminated |
| D-1087-2022 | 04-13-2022 | Kinevac (Sincalide for Injection), 5mcg per vial, 10 vials per box, Rx only, MFG: Bracco Diagnostics Inc., NDC 0270-0556-15 Package NDCs: 0270-0556-15 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 boxes | Class II | Terminated |
| 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-1108-2022 | 04-13-2022 | Tropicamide Ophthalmic Solution, USP 1%, 3 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 6131435502 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 31 bottles | 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-1030-2022 | 04-13-2022 | Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 8 cases | Class II | Terminated |
| D-1120-2022 | 04-13-2022 | Intralipid (I.V. Fat emulsion), 20%, 100 mL bag, Rx only, MFG: Baxter Healthcare, NDC 0338-0519-58 Package NDCs: 0338-0519-58; 0338-0519-09; 0338-0519-13 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 2 cases | Class II | Terminated |
| D-0994-2022 | 04-13-2022 | Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20 Package NDCs: 24208-539-20 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 45 kits | 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-1061-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) single dose vial (NDC 6714-088-01) b) 25-count box (NDC16714-088-25), Rx only, MFG: NorthstarRx/Teva Pharma USA | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 885 vials | Class II | Terminated |
| D-1010-2022 | 04-13-2022 | Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 case | Class II | Terminated |
| D-1072-2022 | 04-13-2022 | MethyLPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL), 10 mL multi-dose vial, Rx only, MFG: Teva Pharma USA, NDC 0703-0045-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 796 cartons/1 vial each | Class II | Terminated |
| D-1005-2022 | 04-13-2022 | Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 2 cartons/2 single dose vials | Class II | Terminated |
| D-1002-2022 | 04-13-2022 | Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 32 cartons/25 vials each | Class II | Terminated |
| D-1067-2022 | 04-13-2022 | Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54 Package NDCs: 0591-2927-54 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 2 inhalers | Class II | Terminated |
| D-1006-2022 | 04-13-2022 | Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol Chemical Co, NDC 12870-0001-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 18 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-1079-2022 | 04-13-2022 | Vecuronium Bromide for Injection, 10 mg (1mg/ mL) vial, 10-count box, Rx only, MFG: Teva Pharma USA, NDC 0703-2914-03 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 20 cartons/10 vials each | Class II | Terminated |
| D-1000-2022 | 04-13-2022 | Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 34 cartons/ 25 vials each | Class II | Terminated |
| D-1100-2022 | 04-13-2022 | Verapamil HCL, ampule, 2.5 mg/ML 2ML (5/pack), Rx only, MFG: Pfizer, NDC 04094-011-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 14 packs/ 5 per pack | Class II | Terminated |
| D-1069-2022 | 04-13-2022 | Medroxyprogesterone acetate injectable suspension, USP, 150 mg/mL, 1 mL vials, packaged in a) single dose vial (NDC 0703-6801-01), b) 25-count box single dose vials (NDC 0703-6801-04), Rx only, MFG: Teva Pharma USA | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 89 cartons/25 vials per carton and 3 cartons/1 vial | 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-1015-2022 | 04-13-2022 | Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 25 kits | 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-1099-2022 | 04-13-2022 | Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-215-05 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 157 kits | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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; 0002-7533-01; 0002-8799-01; 0002-8799-59; 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 | 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-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-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-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-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-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-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-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-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-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-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-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-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 |
