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-0880-202205-03-2022Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.American Health Packaging / 1603 cartonsClass IIITerminated
D-0881-202205-03-2022Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.Apotex Corp. / 2353 bottlesClass IIITerminated
D-0855-202205-02-2022MVASI (bevacizumab-awwb), Injection, For Intravenous Infusion After Dilution, 100 mg/4 ml, Single dose vial, Rx only, Manufactured by Amgen Inc. Thousand Oaks, CA 91320-1799, NDC 55513-0206-01Defective container: loose crimp defect, potential loss of container integrity.Amgen, Inc. / 15,823Class IITerminated
D-0887-202205-02-2022Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.RemedyRepack Inc. / 30 bottles/90 count = 2,700 tabletsClass IITerminated
D-0886-202205-02-2022Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.RemedyRepack Inc. / 26/90 count bottles = 2,340 tabletsClass IITerminated
D-0890-202204-29-2022Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25 g) per tube, Active Ingredients: Oxtinoxate (7.5%), Oxybenzone (3%); Distributed by: Higher Education Skincare, 1.833.251.0388Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.Eco Lips, Inc / 17,000 unitsClass IIITerminated
D-0858-202204-29-2022buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-738-86
Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.SUN PHARMACEUTICAL INDUSTRIES INC / 744 bottlesClass IIITerminated
D-0857-202204-29-2022buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Halol-Baroda Highway, Halol-389 350, Gujarat, India
Package NDCs: 47335-736-86; 47335-736-88; 47335-736-08; 47335-736-13; 47335-737-86; 47335-737-88; 47335-737-08; 47335-737-13; 47335-738-86; 47335-738-88; 47335-738-08; 47335-738-13
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.SUN PHARMACEUTICAL INDUSTRIES INC / 9804 bottlesClass IIITerminated
D-0844-202204-28-2022alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-0068-1.
Package NDCs: 59762-0057-1; 59762-0059-1; 59762-0066-1; 59762-0068-1
Failed Dissolution Specifications: low out-of-specification dissolution test results observed.Viatris Inc / 6,789 bottlesClass IITerminated
D-0854-202204-28-2022Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of Fizer Inc, NY, NY 10017, NDC 0009-0068-07.Failed Dissolution Specifications: low out of specification results for dissolution.Viatris Inc / 110 bottlesClass IITerminated
D-0875-202204-27-2022GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19
Package NDCs: 43386-060-19
Failed Stability SpecificationLupin Pharmaceuticals Inc. / 26,910 bottlesClass IITerminated
D-0879-202204-27-2022Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint Naturally Flavored, packaged in Bags of 30 lozenges, Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 96566-0009, UPC 0 79893 41266 5Subpotent drug: Low OOS for menthol content at the three month room temperature.Bestco LLC / 2038 bagsClass IIITerminated
D-0831-202204-25-2022Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0924-44CGMP DeviationsSCA Pharmaceuticals / 30 bagsClass IITerminated
D-0830-202204-25-2022Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-0231-32CGMP DeviationsSCA Pharmaceuticals / 424 bagsClass IITerminated
D-0829-202204-25-2022Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals Windsor, CT 06095, NDC 70004-078-40CGMP DeviationsSCA Pharmaceuticals / 120 bagsClass IITerminated
D-0793-202204-25-2022Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05
cGMP deviationsGlenmark Pharmaceuticals Inc., USA / a) 7,044 bottles; b) 1,014 bottlesClass IICompleted
D-0792-202204-25-2022Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05
cGMP deviationsGlenmark Pharmaceuticals Inc., USA / 12,003 bottlesClass IICompleted
D-0791-202204-25-2022Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
Package NDCs: 68462-128-01; 68462-128-05; 68462-129-01; 68462-129-05; 68462-130-01; 68462-130-05
cGMP deviationsGlenmark Pharmaceuticals Inc., USA / 11,136 bottlesClass IICompleted
D-0873-202204-22-2022Accupril (Quinapril HCl Tablets) 20 mg, 90 Tablets, Rx only NDC 0071-0532-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Pfizer Inc. / 10,304 bottlesClass IITerminated
D-0874-202204-22-2022Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Pfizer Inc. / 8346 bottlesClass IITerminated
D-0872-202204-22-2022Accupril (Quinapril HCl Tablets) 10 mg, 90 Tablets Rx only NDC 0071-0530-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017CGMP Deviations: Contains N-nitrosoquinapril above the acceptable limits.Pfizer Inc. / 2079 bottlesClass IITerminated
D-0786-202204-21-2022TORCO RACING FUELS HAND SANITIZER, Alcohol Antiseptic 80% Topical Solution, Hand Sanitizer Non-Sterile Solution, FDA Approved, 76590-8347-1, 3780 mL, 3.78 Liters (1 Gallon). Torco Race Fuels 2527 W. Dallas Ave. Apache Junction, AZ, 85120CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.Torco Race Fuels / 127 gallonsClass IITerminated
D-0851-202204-21-2022Erythromycin Topical Gel USP, 2%, Net Wt 60 g tube, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-053-68CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.McKesson Corporation dba McKesson Drug Company / 5,640 tubesClass IIOngoing
D-0848-202204-21-2022Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.McKesson Corporation dba McKesson Drug Company / 81,757 bottlesClass IIOngoing
D-0847-202204-21-2022Halobetasol Propionate Ointment 0.05% Net Wt., 50 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-998-67CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.McKesson Corporation dba McKesson Drug Company / 13, 200 tubesClass IIOngoing
D-0850-202204-21-2022Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.McKesson Corporation dba McKesson Drug Company / 55,440 tubesClass IIOngoing
D-0849-202204-21-2022Lidocaine Prilocaine Cream USP, 2.5%/2.5% Net Wt. 30 gram tube, Rx Only, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141 Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, NDC 63739-054-66CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.McKesson Corporation dba McKesson Drug Company / 1176 tubesClass IIOngoing
D-0846-202204-15-2022Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701, NDC 50383-775-04Failed viscosity specification - product was below specificcationAkorn, Inc. / 66,744 bottlesClass IIITerminated
D-0832-202204-15-2022Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tabletsClass IITerminated
D-0834-202204-15-2022Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tabletsClass IITerminated
D-0833-202204-15-2022Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-044-10; 33342-044-12; 33342-044-07; 33342-044-44; 33342-045-10; 33342-045-12; 33342-045-07; 33342-045-44; 33342-046-10; 33342-046-12; 33342-046-07; 33342-046-44
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tabletsClass IITerminated
D-0835-202204-15-2022Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / N/AClass IITerminated
D-0836-202204-15-2022Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / N/AClass IITerminated
D-0837-202204-15-2022Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Package NDCs: 33342-050-07; 33342-050-10; 33342-050-44; 33342-050-12; 33342-051-07; 33342-051-10; 33342-051-44; 33342-051-12; 33342-052-07; 33342-052-10; 33342-052-44; 33342-052-12
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limitsMacleods Pharma Usa Inc / N/AClass IITerminated
D-0853-202204-15-2022Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, NDC 43598-561-78.Failed Dissolution SpecificationsDr. Reddy's Laboratories, Inc. / 252 Blister PacksClass IITerminated
D-1168-202204-15-2022Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704Subpotent drugValor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy / 950 mLs in 1x8 oz and 2x16 oz bottles.Class ITerminated
D-1167-202204-15-2022Tacrolimus (Brand Capsules ) 0.5 mg/mL Suspension, Rx, This is a compounded medication., Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704,Subpotent drugValor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy / 1,966 mLs in 12 oz; 2 oz; 16 oz and 6 oz bottlesClass ITerminated
D-0794-202204-15-2022Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USAcGMP DeviationsTeva Pharmaceuticals USA Inc / 353964 unitsClass IITerminated
D-0878-202204-14-2022Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC Tampa, FL 33624, NDC 69367-172-16Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol contentMonarch PCM, LLC / 15,730 bottlesClass IIITerminated
D-1051-202204-13-2022Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial Diluent for Glucagon, 1ml syringe, Rx only, MFG: Eli Lilly, NDC 0002-8031-01cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 13 syringesClass IITerminated
D-1014-202204-13-2022Epinephrine Injection, USP, Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma NDC 49502-101-02
Package NDCs: 49502-102-01; 49502-102-02; 49502-101-01; 49502-101-02
cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 30 packsClass IITerminated
D-1012-202204-13-2022EPI-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
Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92
cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 4 cartons/2 auto injectors eachClass IITerminated
D-1011-202204-13-2022Dihydroergotamine Mesylate, Injection, USP, 1mg/mL, packaged in box of 5 x 1 mL ampules, Rx only, Manufactured for: Perrigo, Minneapolis, MN, NDC 0574-0850-10cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 cartonClass IITerminated
D-0993-202204-13-2022EPI-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 abuseMckesson Medical-Surgical Inc. Corporate Office / 5 cartonsClass IITerminated
D-1040-202204-13-2022Ipratropium 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 57 pouchesClass IITerminated
D-1042-202204-13-2022Olanzapine 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 49884-321-55cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 30 cartons/3 blister packs per cartonClass IITerminated
D-1048-202204-13-2022Metronidazole Vaginal Gel USP, 0.75% with 5 applicators, Net Wt. 70 g tube, Rx only, MFG: Sandoz, NDC 0781-7077-87cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 7 tubesClass IITerminated
D-1038-202204-13-2022Glucagen (glucagon) for injection, packaged in a 10-count box, (10 vials each containing 1 mg per vial), Rx only, MFG: Boehringer Mannheim, NDC 0597-0053-45cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vials per cartonClass IITerminated
D-1114-202204-13-2022Ofloxacin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 cartonClass IITerminated
D-1105-202204-13-2022Prednisolone 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 50 bottlesClass IITerminated
D-1093-202204-13-2022Prazosin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 8 bottles/100 tablets eachClass IITerminated
D-1013-202204-13-2022Epinephrine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 55 packsClass IITerminated
D-1027-202204-13-2022Aprepitant 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 29 boxesClass IITerminated
D-1041-202204-13-2022ClomiPHENE Citrate Tablets, USP 50 mg, 30-count bottle, Rx only, MFG: PAR Pharma, NDC 49884-701-55cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 240 cartons/3 blister packs per cartonClass IITerminated
D-1083-202204-13-2022Transderm 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 56 cartons/10 patches eachClass IITerminated
D-1118-202204-13-2022Cefazolin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 39 casesClass IITerminated
D-1026-202204-13-2022Aparaclonidine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 21 bottlesClass IITerminated
D-0998-202204-13-2022Bupivacaine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 224 cartons/10 vials eachClass IITerminated
D-1082-202204-13-2022Recothrom 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 110 cartons/5000 units eachClass IITerminated
D-1037-202204-13-2022Meclizine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 box/50 blister packs per boxClass IITerminated
D-1103-202204-13-2022Ondansetron 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 2 bottles/500 tablets eachClass IITerminated
D-1059-202204-13-2022Sulfamethoxazole 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 32 cartons/100 blister packs per cartonClass IITerminated
D-1068-202204-13-2022Lidocaine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/30 pouchesClass IITerminated
D-1020-202204-13-2022Albuterol 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 96 pouchesClass IITerminated
D-1094-202204-13-2022Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG: Par Pharma, NDC 49884-122-01cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 bottle/100 tabletsClass IITerminated
D-1024-202204-13-2022Albuterol 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 aerosolClass IITerminated
D-1104-202204-13-2022Pantoprazole Sodium for Injection, 40 mg/vial, 10 single-dose vials, Rx only, MFG: Sandoz Pharma, NDC 0781-3232-95cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vialsClass IITerminated
D-1009-202204-13-2022Ampicillin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 10 cartons/10 vials eachClass IITerminated
D-1032-202204-13-2022Doxycycline 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 3 bottlesClass IITerminated
D-1075-202204-13-2022Mupirocin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 5 tubesClass IITerminated
D-1117-202204-13-2022Cefazolin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 26 casesClass IITerminated
D-1039-202204-13-2022Naltrexone 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 4 bottles/30 tablets per bottleClass IITerminated
D-1088-202204-13-2022Levofloxacin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 box/100 blisters packs per boxClass IITerminated
D-0997-202204-13-2022Azithromycin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 13 carton/10 vials eachClass IITerminated
D-1085-202204-13-2022E-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 abuseMckesson Medical-Surgical Inc. Corporate Office / 16 boxes/50 pouches per boxClass IITerminated
D-1115-202204-13-2022Diprivan (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 abuseMckesson Medical-Surgical Inc. Corporate Office / 122 cartonsClass IITerminated
D-1053-202204-13-2022Xylocaine + 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 33 trays/25 vials per trayClass IITerminated
D-1034-202204-13-2022BSS 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 4 bottlesClass IITerminated
D-1022-202204-13-2022Adrenalin (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 abuseMckesson Medical-Surgical Inc. Corporate Office / 58 cartonsClass IITerminated
D-1019-202204-13-2022Albuterol 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 23 pouchesClass IITerminated
D-1096-202204-13-2022Depo-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 abuseMckesson Medical-Surgical Inc. Corporate Office / 2 cartonsClass IITerminated
D-1097-202204-13-2022Depo-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 abuseMckesson Medical-Surgical Inc. Corporate Office / 177 cartonsClass IITerminated
D-1106-202204-13-2022Triamcinolone 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 30 tubesClass IITerminated
D-1025-202204-13-2022Amoxicillin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 12 bottlesClass IITerminated
D-1045-202204-13-2022Hydrocortisone 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 tubeClass IITerminated
D-1047-202204-13-2022Lidocaine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 23 tubesClass IITerminated
D-1116-202204-13-2022Diprivan (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 abuseMckesson Medical-Surgical Inc. Corporate Office / 46 cartonsClass IITerminated
D-1055-202204-13-2022Ibuprofen 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/100 blisters per cartonClass IITerminated
D-1049-202204-13-2022Nitrostat (Nitroglycerin Sublingual Tablets, USP) 0.4 mg/tablet, 25-count bottle, Rx only, Distributed by: Pfizer Parke-Davis, Division of Pfizer Inc., NDC 0071-0418-13cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/4 bottles per carton/25 tablets per bottleClass IITerminated
D-1065-202204-13-2022Ketoconazole 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 6 tubesClass IITerminated
D-1031-202204-13-2022Sterile 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 abuseMckesson Medical-Surgical Inc. Corporate Office / unknownClass IITerminated
D-1112-202204-13-2022Geodon for injection (ziprasidone mesylate), 20 mg/mL, 1 mL single dose vial, Rx only, MFG: Viatris, NDC 0049-3920-83cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/10 vialsClass IITerminated
D-1054-202204-13-2022Doxycycline 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 108 cartons/50 blisters per cartonClass IITerminated
D-1028-202204-13-2022Betamethasone 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; 0168-0057-60
cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 1 tubeClass IITerminated
D-0995-202204-13-2022TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Package NDCs: 0078-0876-01
cGMP deviations: Temperature abuseMckesson Medical-Surgical Inc. Corporate Office / 3 tubesClass IITerminated
D-1046-202204-13-2022HydrOXYzine 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 30 bottles/100 capsules per bottleClass IITerminated
D-1021-202204-13-2022Ipratropium 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 56 pouchesClass IIITerminated
D-1102-202204-13-2022Neomycin 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 120 tubesClass IITerminated
D-1018-202204-13-2022Albuterol 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 1 carton/30 pouches eachClass IITerminated
D-1033-202204-13-2022BSS 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 abuseMckesson Medical-Surgical Inc. Corporate Office / 13 bottlesClass IITerminated