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-1115-2022 | 04-13-2022 | Diprivan (Propofol) Emulsion, 100 mg/mL, 10mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-10 Package NDCs: 63323-269-30; 63323-269-50; 63323-269-35; 63323-269-65; 63323-269-22; 63323-269-29; 63323-269-01; 63323-269-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 122 cartons | Class II | Terminated |
| D-1040-2022 | 04-13-2022 | Ipratropium Bromide Inhalation Solution, 0.02%, 0.5 mg/2.5 mL, packaged in 25-count box (25 x 2.5 mL sterile unit-dose vials), Rx only, MFG: Nephron Pharma, NDC 0487-9801-25 Package NDCs: 0487-9801-25; 0487-9801-30; 0487-9801-60; 0487-9801-01; 0487-9801-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 57 pouches | Class II | Terminated |
| D-1042-2022 | 04-13-2022 | Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 30 cartons/3 blister packs per carton | Class II | Terminated |
| D-1048-2022 | 04-13-2022 | Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 7 tubes | Class II | Terminated |
| D-1026-2022 | 04-13-2022 | Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05 Package NDCs: 61314-665-05; 61314-665-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 21 bottles | Class II | Terminated |
| D-1118-2022 | 04-13-2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3105-11 Package NDCs: 0264-3103-11; 0264-3105-11; 0264-3107-11 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 39 cases | Class II | Terminated |
| D-1083-2022 | 04-13-2022 | Transderm Scop (scopolamine) Transdermanl System, 1 mg/ 3 days, 10 (patches) transdermal Systems Multipack, Rx only, MFG: Baxter Healthcare Corp, NDC 10019-553-03 Package NDCs: 10019-553-03; 10019-553-04; 10019-553-90; 10019-553-06; 10019-008-10; 10019-008-24; 10019-008-01; 10019-008-04 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 56 cartons/10 patches each | Class II | Terminated |
| D-0998-2022 | 04-13-2022 | Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10 Package NDCs: 55150-167-10; 55150-168-30; 55150-169-10; 55150-170-30; 55150-171-10; 55150-172-30; 55150-249-50; 55150-250-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 224 cartons/10 vials each | Class II | Terminated |
| D-1114-2022 | 04-13-2022 | Ofloxacin Otic Solution 0.3%, 5 mL bottle, Rx only, MFG: Amneal/Akyma Pharmaceuticals, NDC 69238-1615-3 Package NDCs: 69238-1616-6; 69238-1615-3 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton | Class II | Terminated |
| D-1038-2022 | 04-13-2022 | Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vials per carton | Class II | Terminated |
| D-1093-2022 | 04-13-2022 | Prazosin Hydrochloride Capsules, USP, 1 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-1101-01 Package NDCs: 0378-1101-01; 0378-1101-10; 0378-2302-01; 0378-2302-10; 0378-3205-01; 0378-3205-25 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 8 bottles/100 tablets each | Class II | Terminated |
| D-1105-2022 | 04-13-2022 | Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05 Package NDCs: 61314-637-05; 61314-637-10; 61314-637-15 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 50 bottles | Class II | Terminated |
| D-1027-2022 | 04-13-2022 | Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06 Package NDCs: 0781-2321-06; 0781-2321-51; 0781-2322-06; 0781-2322-68; 0781-2322-46; 0781-4063-36; 0781-2323-06; 0781-2323-68 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 29 boxes | Class II | Terminated |
| D-1013-2022 | 04-13-2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-102-02 Package NDCs: 49502-102-01; 49502-102-02; 49502-101-01; 49502-101-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 55 packs | Class II | Terminated |
| D-1116-2022 | 04-13-2022 | Diprivan (Propofol) Emulsion, 200 mg per 20 mL (10mg/mL), 20 mL vial, Rx only, MFG: App Pharmaceutical LLC, NDC 63323-269-29 Package NDCs: 63323-269-30; 63323-269-50; 63323-269-35; 63323-269-65; 63323-269-22; 63323-269-29; 63323-269-01; 63323-269-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 46 cartons | Class II | Terminated |
| D-1041-2022 | 04-13-2022 | ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 240 cartons/3 blister packs per carton | Class II | Terminated |
| D-1082-2022 | 04-13-2022 | Recothrom Thrombin Topical (Recombinant), 5,000 units, packaged in a box containing a 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label, Rx only, MFG: Baxter, NDC# 0338-0322-01 Package NDCs: 0338-0322-01; 0338-0324-01; 0338-0326-01; 0338-0328-01; 0338-0330-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 110 cartons/5000 units each | Class II | Terminated |
| D-1104-2022 | 04-13-2022 | Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vials | Class II | Terminated |
| D-1103-2022 | 04-13-2022 | Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30 Package NDCs: 65862-187-30; 65862-187-05; 65862-187-99; 65862-187-03; 65862-187-10; 65862-188-30; 65862-188-05; 65862-188-99; 65862-188-03; 65862-188-10; 65862-189-11 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 2 bottles/500 tablets each | Class II | Terminated |
| D-1054-2022 | 04-13-2022 | Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06 Package NDCs: 0904-0430-95; 0904-0430-04; 0904-0430-06 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 108 cartons/50 blisters per carton | Class II | Terminated |
| D-1009-2022 | 04-13-2022 | Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10 Package NDCs: 55150-111-10; 55150-112-10; 55150-113-10; 55150-114-20 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 10 cartons/10 vials each | Class II | Terminated |
| D-1117-2022 | 04-13-2022 | Cefazolin for injection USP, and Dextrose Injection, USP, 1G, 50 ML duplex container, Rx only, MFG: B. Braun Medical Inc., NDC 0264-3103-11 Package NDCs: 0264-3103-11; 0264-3105-11; 0264-3107-11 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 26 cases | Class II | Terminated |
| D-1032-2022 | 04-13-2022 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50 Package NDCs: 63304-614-20; 63304-614-05; 63304-614-01; 63304-614-13; 63304-615-05; 63304-615-11; 63304-615-01; 63304-616-20; 63304-616-05; 63304-616-01; 63304-616-13; 63304-616-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 3 bottles | Class II | Terminated |
| D-1055-2022 | 04-13-2022 | Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61 Package NDCs: 0904-5853-61; 0904-5853-60; 0904-5853-40; 0904-5854-61; 0904-5854-60; 0904-5854-40; 0904-5855-61; 0904-5855-60; 0904-5855-40 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/100 blisters per carton | Class II | Terminated |
| D-1075-2022 | 04-13-2022 | Mupirocin Ointment, USP 2%, 22 grams tube, Rx only, MFG: Teva Pharma USA, NDC 0093-1010-42, MFG: Teva Pharma USA Package NDCs: 0093-1010-42 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 tubes | Class II | Terminated |
| D-1011-2022 | 04-13-2022 | Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton | Class II | Terminated |
| D-0993-2022 | 04-13-2022 | EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialty LP., NDC 49502-500-02 Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 5 cartons | Class II | Terminated |
| D-0995-2022 | 04-13-2022 | TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01 Package NDCs: 0078-0876-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 3 tubes | Class II | Terminated |
| D-1034-2022 | 04-13-2022 | BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50 Package NDCs: 0065-0795-15; 0065-0795-30; 0065-0795-25; 0065-0795-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 4 bottles | Class II | Terminated |
| D-1085-2022 | 04-13-2022 | E-Z-Gas II, Effervescent Granules, Net Weight: 4 g, 50 packets per box, MFG: Bracco Diagnostics Inc., NDC 0270-9020-01 (discontinued), NDC 10361-793-01 (current) Package NDCs: 10361-793-01; 0270-9020-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 16 boxes/50 pouches per box | Class II | Terminated |
| D-1102-2022 | 04-13-2022 | Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36 Package NDCs: 61314-631-36 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 120 tubes | Class II | Terminated |
| D-1021-2022 | 04-13-2022 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL vial, packaged in a) 30-count (NDC 0487-0201-03), b) 60-count (NDC 0487-0201-60), Rx only, MFG: Nephron Pharma Package NDCs: 0487-0201-01; 0487-0201-02; 0487-0201-03; 0487-0201-60 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 56 pouches | Class III | Terminated |
| D-1046-2022 | 04-13-2022 | HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01 Package NDCs: 0185-0674-10; 0185-0674-05; 0185-0674-01; 0185-0615-10; 0185-0615-05; 0185-0615-01; 0185-0613-10; 0185-0613-05; 0185-0613-01; 0185-0676-10; 0185-0676-05; 0185-0676-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 30 bottles/100 capsules per bottle | Class II | Terminated |
| D-1033-2022 | 04-13-2022 | BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15 Package NDCs: 0065-0795-15; 0065-0795-30; 0065-0795-25; 0065-0795-50 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 13 bottles | Class II | Terminated |
| D-1053-2022 | 04-13-2022 | Xylocaine + Epinephrine, multi dose vial 2%, 20 mL, 25 count box, Rx only, MFG: Fresenius Kabi USA LLC, NDC 63323-483-27 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 / 33 trays/25 vials per tray | Class II | Terminated |
| 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-1018-2022 | 04-13-2022 | Albuterol Sulfate Inhalation Solution, 0.021%, 0.63 mg/3mL, packaged in 30 x 3 mL Sterile Unit-Dose Vials, Rx only, MFG: Nephron Pharma, NDC 0487-0301-01 Package NDCs: 0487-9904-25; 0487-9904-01; 0487-9904-02; 0487-0301-01; 0487-0301-02 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/30 pouches each | Class II | Terminated |
| D-1096-2022 | 04-13-2022 | Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 40 mg/mL, 1 mL single-dose vial, Rx only, MFG: Pfizer, NDC 0009-3073-03 Package NDCs: 0009-3073-01; 0009-3073-03; 0009-3475-01; 0009-3475-03 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 2 cartons | Class II | Terminated |
| D-1106-2022 | 04-13-2022 | Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15 Package NDCs: 0168-0003-15; 0168-0003-80; 0168-0004-15; 0168-0004-80; 0168-0004-16; 0168-0002-15 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 30 tubes | Class II | Terminated |
| D-1097-2022 | 04-13-2022 | Depo-Medrol (methylprednisolone acetate injectable suspension, USP) 80mg/mL, packaged in a) 1 mL single-dose vial (NDC# 0009-3475-01), b) 25-count box (NDC 0009-3475-03), Rx only, MFG: Pfizer Package NDCs: 0009-3073-01; 0009-3073-03; 0009-3475-01; 0009-3475-03 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 177 cartons | Class II | Terminated |
| D-1094-2022 | 04-13-2022 | Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 bottle/100 tablets | Class II | Terminated |
| D-1024-2022 | 04-13-2022 | Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85 Package NDCs: 0781-7296-85 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 aerosol | Class II | Terminated |
| D-1043-2022 | 04-13-2022 | Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16 Package NDCs: 0603-1880-10; 0603-1880-16 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 3 cartons/30 pouches per carton | Class II | Terminated |
| D-1059-2022 | 04-13-2022 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61 Package NDCs: 0904-2725-61 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 32 cartons/100 blister packs per carton | Class II | Terminated |
| D-1088-2022 | 04-13-2022 | Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61 Package NDCs: 0904-6351-61; 0904-6352-61; 0904-6353-61 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 box/100 blisters packs per box | Class II | Terminated |
| D-1037-2022 | 04-13-2022 | Meclizine Hydrochloride Tablets, USP, 25 mg, 50-count cartons (5 x10 unit dose), 10 Tablets per card, 5 cards per carton, Rx only, MFG: Avkare Inc., NDC 50268-523-15 Package NDCs: 50268-522-11; 50268-522-15; 50268-523-11; 50268-523-15 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 box/50 blister packs per box | Class II | Terminated |
| D-1068-2022 | 04-13-2022 | Lidocaine Patch 5%, 30-count box, Rx only, MFG: Teva Pharma USA, NDC 0591-3525-30 Package NDCs: 0591-3525-11; 0591-3525-30 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/30 pouches | Class II | Terminated |
| D-1020-2022 | 04-13-2022 | Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 25 X 3mL unit-dose vials, Rx only, MFG by: Nephron Pharma, NDC 0487-9501-25 Package NDCs: 0487-9501-25; 0487-9501-03; 0487-9501-60; 0487-9501-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 96 pouches | Class II | Terminated |
| D-1031-2022 | 04-13-2022 | Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06 Package NDCs: 0338-0013-06; 0338-0013-08; 0338-0013-29 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / unknown | 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-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-1025-2022 | 04-13-2022 | Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01 Package NDCs: 0781-2020-31; 0781-2020-76; 0781-2020-01; 0781-2020-05; 0781-2613-31; 0781-2613-76; 0781-2613-01; 0781-2613-05; 0781-5060-20; 0781-5060-01; 0781-5061-20; 0781-5061-01; 0781-6039-58; 0781-6039-46; 0781-6039-55; 0781-6156-52; 0781-6156-57; 0781-6156-46; 0781-6041-58; 0781-6041-46; 0781-6041-55; 0781-6157-52; 0781-6157-57; 0781-6157-46 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 12 bottles | 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-1112-2022 | 04-13-2022 | Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial, Rx only, MFG: Viatris, NDC 0049-3920-83 Package NDCs: 0049-3960-60; 0049-3980-60; 0049-3990-60; 0049-3920-20; 0049-3920-83; 0049-3920-01; 0049-3920-10; 0049-0052-60; 0049-0054-60; 0049-0056-60; 0049-0058-60; 0049-0352-60; 0049-0354-60; 0049-0356-60; 0049-0358-60 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vials | Class II | Terminated |
| D-1022-2022 | 04-13-2022 | Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01 Package NDCs: 42023-159-01; 42023-159-25; 42023-168-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 58 cartons | Class II | Terminated |
| D-1019-2022 | 04-13-2022 | Albuterol Sulfate Inhalation Solution 0.083%, 2.5 mg/3mL, packaged in 5 x 3 mL unit-dose vials, Rx only, Manufactured by: Nephron Pharma, NDC 0487-9501-03 Package NDCs: 0487-9501-25; 0487-9501-03; 0487-9501-60; 0487-9501-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 23 pouches | Class II | Terminated |
| D-1045-2022 | 04-13-2022 | Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30 Package NDCs: 0168-0146-16; 0168-0146-30; 0168-0080-16; 0168-0080-31 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 tube | Class II | Terminated |
| D-1049-2022 | 04-13-2022 | Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 carton/4 bottles per carton/25 tablets per bottle | Class II | Terminated |
| D-1065-2022 | 04-13-2022 | Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60 Package NDCs: 0168-0099-15; 0168-0099-30; 0168-0099-60 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 6 tubes | Class II | Terminated |
| D-1047-2022 | 04-13-2022 | Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56 Package NDCs: 0168-0357-05; 0168-0357-55; 0168-0357-56; 0168-0357-30 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 23 tubes | Class II | Terminated |
| D-1028-2022 | 04-13-2022 | Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46 Package NDCs: 0168-0055-15; 0168-0055-46; 0168-0056-15; 0168-0056-46; 0168-0057-60 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 1 tube | 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-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-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-1039-2022 | 04-13-2022 | Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03 Package NDCs: 0406-1170-03; 0406-1170-01 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 4 bottles/30 tablets per bottle | 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-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-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-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-0997-2022 | 04-13-2022 | Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10 Package NDCs: 55150-174-10 | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office / 13 carton/10 vials each | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
