Food, drugs, devices › Mckesson Medical-Surgical Inc. Corporate Office
Drug recall: EPI-PEN 2-PAK (epinephrine injection, USP), Single-Dose Auto-Injectors 0.3 mg, Rx only, Manufactured for: Mylan Specialt
Mckesson Medical-Surgical Inc. Corporate Office (Richmond, VA) initiated this drug recall on 13 Apr 2022; FDA lists 130 product records under event 89646, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 30 Nov 2023. Initiation: voluntary: firm initiated. Mckesson Medical-Surgical Inc. Corporate Office has 15 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA.
Reason for recall
"cGMP deviations: Temperature abuse"
Distribution
"USA nationwide."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0993-2022 | 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 | 5 cartons | Class II | Terminated | 15 Jun 2022 |
| D-0994-2022 | Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), Rx only, Manufacturer: Bausch & Lomb, NDC 24208-539-20 | 45 kits | Class II | Terminated | 15 Jun 2022 |
| D-0995-2022 | TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01 | 3 tubes | Class II | Terminated | 15 Jun 2022 |
| D-0996-2022 | Topex (benzocaine 20%), Topical Anesthetic Gel Strawberry, 1 oz, Rx only, Manufacturer: DS Healthcare, NDC 0699-5116-01 | 24 bottles | Class II | Terminated | 15 Jun 2022 |
| D-0997-2022 | Azithromycin for Injection USP Vial, 500 mg per vial, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-174-10 | 13 carton/10 vials each | Class II | Terminated | 15 Jun 2022 |
| D-0998-2022 | Bupivacaine HCl Injection, single dose vial, Preservative Free 0.5%, 10mL (25/ct), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-169-10 | 224 cartons/10 vials each | Class II | Terminated | 15 Jun 2022 |
| D-0999-2022 | Bupivacaine HCl Injection, single dose vial, 0.5%, 30 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0170-30 | 4 cartons/25 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1000-2022 | Bupivacaine HCl Injection, Multi dose vial, 0.25%, 50 mL/2.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0249-50 | 34 cartons/ 25 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1001-2022 | Bupivacaine HCl Injection, Multi dose vial, 0.50%, 50 mL/5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0250-50 | 16 cartons/24 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1002-2022 | Bupivacaine HCl Injection, Single Dose Vial, 0.75%, 10 mL/7.5 mg/mL, Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0171-10 | 32 cartons/25 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1003-2022 | Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, Manufacturer: Auromedics Pharma LLC, NDC 55150-0209-02 | 5 cartons/2 ml single dose vials | Class II | Terminated | 15 Jun 2022 |
| D-1004-2022 | Lidocaine Patch, 5%, 30-count box, Rx only, Manufacturer: Rhodes Pharmaceuticals, NDC 42858-0118-30 | 1 carton/30 patches | Class II | Terminated | 15 Jun 2022 |
| D-1005-2022 | Olanzapine single dose vial Lyophilized, 10 mg, Rx only, MFG: Auromedics Pharma LLC, NDC# 55150-0308-01 | 2 cartons/2 single dose vials | Class II | Terminated | 15 Jun 2022 |
| D-1006-2022 | Arzol (Silver Nitrate Applicator), (Silver Nitrate 75%, Potassium Nitrate 25%), 100-count box, Rx only, Manufacturer: Arzol Chemical Co, NDC 12870-0001-02 | 18 vials | Class II | Terminated | 15 Jun 2022 |
| D-1007-2022 | 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 | 16 single dose vials | Class II | Terminated | 15 Jun 2022 |
| D-1008-2022 | 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 | 799 cartons/1 bottle each | Class II | Terminated | 15 Jun 2022 |
| D-1009-2022 | Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distributed by: Auromedics Pharma, NDC 55150-113-10 | 10 cartons/10 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1010-2022 | Epidural Tray, Nerve Block Single shot, Rx only, # 182207, MFG: Avanos Medical Sales LLC | 1 case | Class II | Terminated | 15 Jun 2022 |
| D-1011-2022 | 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 | 1 carton | Class II | Terminated | 15 Jun 2022 |
| D-1012-2022 | EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02 | 4 cartons/2 auto injectors each | Class II | Terminated | 15 Jun 2022 |
| D-1013-2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.3 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-102-02 | 55 packs | Class II | Terminated | 15 Jun 2022 |
| D-1014-2022 | Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02 | 30 packs | Class II | Terminated | 15 Jun 2022 |
| D-1015-2022 | Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01 | 25 kits | Class II | Terminated | 15 Jun 2022 |
| D-1016-2022 | Firmagon (degarelix for injection) 240 mg, Starting Dose, packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8403-01 | 15 boxes | Class II | Terminated | 15 Jun 2022 |
| D-1017-2022 | GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, Manufactured for: Boehringer Mannheim, NDC 0597-0260-10 | 187 vials | Class II | Terminated | 15 Jun 2022 |
| D-1018-2022 | 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 | 1 carton/30 pouches each | Class II | Terminated | 15 Jun 2022 |
| D-1019-2022 | 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 | 23 pouches | Class II | Terminated | 15 Jun 2022 |
| D-1020-2022 | 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 | 96 pouches | Class II | Terminated | 15 Jun 2022 |
| D-1021-2022 | 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 | 56 pouches | Class III | Terminated | 15 Jun 2022 |
| D-1022-2022 | Adrenalin (epinephrine injection, USP) 30 mg/30 mL (1mg/mL), 30 mL multiple dose vial, Rx only, MFG: Par Pharma, NDC 42023-168-01 | 58 cartons | Class II | Terminated | 15 Jun 2022 |
| D-1023-2022 | Albuterol Sulfate Inhalation Aerosol HFA with Dose Indicator, 90 mcg, 200 metered inhalations, Rx only, Manufactured for: PAR Pharmaceutical, NDC 0254-1007-52 | 5 aerosols | Class II | Terminated | 15 Jun 2022 |
| D-1024-2022 | Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85 | 1 aerosol | Class II | Terminated | 15 Jun 2022 |
| D-1025-2022 | Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01 | 12 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1026-2022 | Aparaclonidine Ophthalmic Solution 0.5% as base, 0.5%, 5 mL bottle, Rx only, MFG:Sandoz Pharma, NDC 61314-665-05 | 21 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1027-2022 | Aprepitant Capsule, USP, 40 mg, 1 capsule per unit dose package, Rx only, MFG: Sandoz Pharma, NDC 0781-2321-06 | 29 boxes | Class II | Terminated | 15 Jun 2022 |
| D-1028-2022 | Betamethasone Dipropionate Cream USP, 0.05%, 45 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0055-46 | 1 tube | Class II | Terminated | 15 Jun 2022 |
| D-1029-2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 10 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc., NDC 61314-0656-10 | 1 bottle | Class II | Terminated | 15 Jun 2022 |
| D-1030-2022 | Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manufacturer: Smiths Medical ASD, Inc., NJ | 8 cases | Class II | Terminated | 15 Jun 2022 |
| D-1031-2022 | Sterile Water for Injection USP, 2000 mL, Rx only, Baxter Healthcare Corp., NDC 0338-0013-06 | unknown | Class II | Terminated | 15 Jun 2022 |
| D-1032-2022 | Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Distributed by: Sun Pharmaceuticals, NDC 63304-616-50 | 3 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1033-2022 | BSS Sterile Irrigating Solution (balanced salt solution), 15 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-15 | 13 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1034-2022 | BSS Sterile Irrigating Solution (balanced salt solution), 500 mL bottle, Rx only, MFG: Alcon Surgical Inc, NDC 0065-0795-50 | 4 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1035-2022 | Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55 | 13 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1036-2022 | MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15 | 8 boxes/12 vials each | Class II | Terminated | 15 Jun 2022 |
| D-1037-2022 | 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 | 1 box/50 blister packs per box | Class II | Terminated | 15 Jun 2022 |
| D-1038-2022 | 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 | 1 carton/10 vials per carton | Class II | Terminated | 15 Jun 2022 |
| D-1039-2022 | Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03 | 4 bottles/30 tablets per bottle | Class II | Terminated | 15 Jun 2022 |
| D-1040-2022 | 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 | 57 pouches | Class II | Terminated | 15 Jun 2022 |
| D-1041-2022 | ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55 | 240 cartons/3 blister packs per carton | Class II | Terminated | 15 Jun 2022 |
| D-1042-2022 | 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 | 30 cartons/3 blister packs per carton | Class II | Terminated | 15 Jun 2022 |
| D-1043-2022 | Lidocaine Patch 5%, 30-count carton, Rx only, MFG: Qualitest Products, NDC 0603-1880-16 | 3 cartons/30 pouches per carton | Class II | Terminated | 15 Jun 2022 |
| D-1044-2022 | Ciprofloxacin Ophthalmic Solution 0.3%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-656-05 | 7 bottles | Class II | Terminated | 15 Jun 2022 |
| D-1045-2022 | Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30 | 1 tube | Class II | Terminated | 15 Jun 2022 |
| D-1046-2022 | HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01 | 30 bottles/100 capsules per bottle | Class II | Terminated | 15 Jun 2022 |
| D-1047-2022 | Lidocaine and Prilocaine Cream, 2.5%/2.5%, 5 gram tubes, Rx only, MFG: Sandoz Pharma, NDC 0168-0357-56 | 23 tubes | Class II | Terminated | 15 Jun 2022 |
| D-1048-2022 | Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87 | 7 tubes | Class II | Terminated | 15 Jun 2022 |
| D-1049-2022 | 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 | 1 carton/4 bottles per carton/25 tablets per bottle | Class II | Terminated | 15 Jun 2022 |
| D-1050-2022 | 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 | 1 vial | Class II | Terminated | 15 Jun 2022 |
| D-1051-2022 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01 | 13 syringes | Class II | Terminated | 15 Jun 2022 |
| D-1052-2022 | 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 | 76 trays/25 vials per tray | Class II | Terminated | 15 Jun 2022 |
Showing 60 of 130 product records; the FDA enforcement report lists all of them.
Context
65%of 2022 drug events are Class II325 events that year
130product records in this eventfirm median: 3
15events on this register for the firm
Other enforcement events for Mckesson Medical-Surgical Inc. Corporate Office
All 15 events for Mckesson Medical-Surgical Inc. Corporate Office
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "cGMP deviations: Temperature abuse"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "USA nationwide."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 30 Nov 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.