1. Home
  2. Drug Recall Enforcement Reports

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 April 12, 2024 and include a total of 16143 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0434-202404-02-2024Cyclophosphamide for Injection, USP, 1g/vial, Lyophilized, Single Dose Vial, Discard unused solution, Cytotoxic Agent, After Reconstitution: For direct intravenous injection or must be further diluted before intravenous infusion, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc., Big Flats, NY 14814, NDC # 39822-0255-01.Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.X-Gen Pharmaceuticals Inc. / 1332 vialsClass IIIOngoing
D-0433-202404-02-2024Cyclophosphamide for Injection, USP, 500mg/vial, Lyophilized, Cytotoxic Agent, Single Dose Vial for Intravenous Use, Rx Only, Manufactured for: XGen Pharmaceuticals DJB, Inc. Big Flats, NY 14814, NDC # 39822-0250-01.Labeling: Incorrect or missing Package Insert: There is an error on the Package Insert (PI), section 2.3, Preparation, Handling, and Administration. The concentration of the reconstituted product is listed as '20 mg per vial.' This information should read: '20 mg per mL'.X-Gen Pharmaceuticals Inc. / 1283 vialsClass IIIOngoing
D-0430-202403-26-2024Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01
Package NDCs: 68462-850-01; 68462-851-01; 68462-562-01		Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.Glenmark Pharmaceuticals Inc., USA / 6,528 bottlesClass IIOngoing
D-0432-202403-22-2024fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-6030-1Lack of Assurance of Sterility: leaking bagsIntegraDose Compounding Services LLC / 187 cassettesClass IIOngoing
D-0431-202403-22-2024Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Package NDCs: 0264-7750-00; 0264-7750-10; 0264-7750-20		Lack of assurance of sterility: bags have the potential to leak..B. Braun Medical Inc / 7,800 bagsClass IIOngoing
D-0427-202403-21-2024VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus Pharmaceutical Corp, Ronkonkoma, NY 11779, NDC 52925-112-01
Package NDCs: 52925-112-01		cGMP DiviationsApothecus Pharmaceutical Corp. / 17,280 paper cartonsClass IIOngoing
D-0392-202403-12-2024Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.Hikma Pharmaceuticals USA Inc. / 22,644 ampulsClass IIOngoing
D-0428-202403-07-2024Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only, Teva Pharmaceuticals USA, INC, North Wales, PA 19454, NDC 0093-2140-62
Package NDCs: 0093-2140-28; 0093-2140-62		Failed Dissolution SpecificationsTeva Pharmaceuticals USA, Inc / 92,676 cartonsClass IIOngoing
D-0370-202403-06-2024Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-1944-20
Package NDCs: 0264-1944-20		Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label, resulting in leaks.B. Braun Medical Inc / 22,752 bagsClass IIOngoing
D-0374-202403-05-2024Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Package NDCs: 82584-001-05; 82584-002-05; 82584-002-15		Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.Thea Pharma, Inc. / 5,476 bottlesClass IIOngoing
D-0369-202403-04-2024Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-060-01.
Package NDCs: 16714-059-01; 16714-060-01		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 7,488 bottlesClass IIOngoing
D-0368-202403-04-2024Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141 , Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India, NDC 16714-059-01.
Package NDCs: 16714-059-01; 16714-060-01		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 47,520 bottlesClass IIOngoing
D-0429-202403-04-2024Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenous Infusion Only, 20 mL Multiple-Dose Vial, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-206-01
Package NDCs: 42023-209-01; 42023-208-01; 42023-207-01; 42023-206-01		Presence of Particulate Matter.Par Sterile Products LLC / 466 vialsClass IOngoing
D-0389-202403-04-2024Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20
Package NDCs: 70954-201-10; 70954-201-20; 70954-202-10; 70954-202-20; 70954-200-10		Cross Contamination with Other Products:(mycophenolate mofetil).Novitium Pharma LLC / 3,940 1000-count bottlesClass IIIOngoing
D-0436-202402-29-2024FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 mL Total Volume per Vial, Intravenous, Rx Only, Hospital/Office Use Only, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-9010-1Lack of Assurance of Sterility: Firm did not perform process validation.SSM Health Care St. Louis DBA SSM St. Clare Health Center / 140 vialsClass IIOngoing
D-0435-202402-29-2024Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing Facility, 1015 Bowles Ave, Fenton, MO 63026-2394. NDC: 60652-0104-1Lack of Assurance of Sterility: Firm did not perform process validation.SSM Health Care St. Louis DBA SSM St. Clare Health Center / 11,798 syringesClass IIOngoing
D-0383-202402-29-2024TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-158-15.Lack of Assurance of SterilityOptikem International, Inc. / 106,704 bottlesClass IIOngoing
D-0377-202402-29-2024TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-040-15.
Package NDCs: 17312-040-15		Lack of Assurance of SterilityOptikem International, Inc. / 9,936 bottlesClass IIOngoing
D-0376-202402-29-2024TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-002-11.
Package NDCs: 17312-002-11		Lack of Assurance of SterilityOptikem International, Inc. / 7,248 bottlesClass IIOngoing
D-0375-202402-29-2024TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-032-15.
Package NDCs: 17312-032-15; 17312-032-99		Lack of Assurance of SterilityOptikem International, Inc. / 30,240 bottlesClass IIOngoing
D-0382-202402-29-2024TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-013-15.
Package NDCs: 17312-013-15; 17312-013-99		Lack of Assurance of SterilityOptikem International, Inc. / 139,656 bottlesClass IIOngoing
D-0381-202402-29-2024TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-027-15.
Package NDCs: 17312-027-15		Lack of Assurance of SterilityOptikem International, Inc. / 19,344 bottlesClass IIOngoing
D-0379-202402-29-2024TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-172-15.
Package NDCs: 17312-172-15		Lack of Assurance of SterilityOptikem International, Inc. / 10,536 bottlesClass IIOngoing
D-0384-202402-29-2024hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150Lack of Assurance of SterilityOptikem International, Inc. / 46,621 bottlesClass IIOngoing
D-0380-202402-29-2024TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-098-15.
Package NDCs: 17312-098-15		Lack of Assurance of SterilityOptikem International, Inc. / 24,216 bottlesClass IIOngoing
D-0378-202402-29-2024TRP Natural Eyes Dryness Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manufactured for TRP Company, Inc, 1575 Delucchi Lane, Suite # 208, Reno, NV, NDC # 17312-178-15.
Package NDCs: 17312-178-15; 17312-178-99		Lack of Assurance of SterilityOptikem International, Inc. / 47,832 bottlesClass IIOngoing
D-0385-202402-22-2024Tobramycin for Injection, USP, 1.2 grams per Pharmacy Bulk Package, Rx Only, For Intravenous Use, PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, Carton NDC 55150-470-06, Vial NDC 55150-470-01.
Package NDCs: 55150-470-01; 55150-470-06		Failed Stability Specification: Water determination was found not complying with specification.Eugia US LLC / 1160 VIALSClass IIOngoing
D-0362-202402-20-2024Moxifloxacin 5mg/ml, 1 ml in a Single- Dose Vial, Rx Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-097-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Denver Solutions, LLC DBA Leiters Health / 10,020 vialsClass IIOngoing
D-0361-202402-20-2024Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Denver Solutions, LLC DBA Leiters Health / 40,090 vialsClass IIOngoing
D-0390-202402-20-2024Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10
Package NDCs: 55150-183-01; 55150-183-10		Failed Impurities/Degradation Specifications: Out of specification for organic impuritiesEugia US LLC / 335,940 vialsClass IIOngoing
D-0364-202402-20-2024Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, NDC 10135-0691-61Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.Contract Pharmaceuticals Limited Canada / 45,875 bottlesClass IIIOngoing
D-0363-202402-20-2024Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.Denver Solutions, LLC DBA Leiters Health / 40,890 vialsClass IIOngoing
D-0366-202402-20-2024Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Package NDCs: 55150-313-25; 55150-313-01; 55150-314-25; 55150-314-01		Failed Dissolution SpecificationsEugia US LLC / 10,080 vialsClass IIOngoing
D-0365-202402-20-2024Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.Contract Pharmaceuticals Limited Canada / 11,750 bottlesClass IIIOngoing
D-0391-202402-20-2024Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11
Package NDCs: 55150-183-02; 55150-183-11		Failed Impurities/Degradation Specifications: Out of specification for organic impuritiesEugia US LLC / 43,920 vialsClass IIOngoing
D-0356-202402-19-2024PROBLEND Antibacterial Foaming Silk All-In-One Foaming Hand Sanitizer & Cleanser, Benzalkonium Chloride 0.13% Antibacterial, a) 1250 mL cases, b) 1 G cases, mountain spring scent, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471.CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.Seatex LLC / 1,450 casesClass IIOngoing
D-0357-202402-19-2024PROBLEND E3 Foaming Hand Sanitizer, All-In-One Foaming Hand Sanitizer & Cleanser, Seatex LLC, 445 TX Hwy 36 Rosenberg, TX 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.Seatex LLC / 274 casesClass IIOngoing
D-0358-202402-19-20247 Eleven FOR GAS ISLAND USE ONLY, Hand Sanitizer, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 330 Gal. cases, Distributed by: Magnus, 16005 Gateway Drive, Suite 300, Frisco, TX 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.Seatex LLC / 3 casesClass IIOngoing
D-0359-202402-19-20247 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.Seatex LLC / 1,282 casesClass IIOngoing
D-0360-202402-19-2024PROBLEND Hand Sanitizer, Refreshing Gel Hand Sanitizer, Ethanol 70% v/v Antiseptic, mountain spring scent, 1250 mL cases, Seatex LLC, 445 TX Hwy 36 Rosenberg, YX 77471CGMP Deviations: deficiencies were identified during an FDA inspection of Seatex's manufacturing facility.Seatex LLC / 480 casesClass IIOngoing
D-0386-202402-16-2024Broncochem Cold & Flu Syrup Kids (acetaminophen, guaifenesin, phenylephrine HCl), packaged in 120 mL bottles, Made in Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-098-44Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.Global Corporation / 9831 bottlesClass IIOngoing
D-0387-202402-16-2024Broncochem Cold & Tea (acetaminophen, phenylephrine, HCl, chlorpheniramine maleate), packaged in 13g sachets, 25 sachets per box, Made in the Dominican Republic Exclusively for Global Corporation Inc, Boca Raton, FL 33187 USA, NDC 65131-097-12
Package NDCs: 65131-097-52; 65131-097-53; 65131-097-12		Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.Global Corporation / 2345 boxesClass IIOngoing
D-0327-202402-13-2024Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
Package NDCs: 69238-1273-6		Failed Impurities/Degradation Specifications: Out-of-specification test results.Amneal Pharmaceuticals of New York, LLC / 46,037 BottlesClass IIOngoing
D-0347-202402-12-2024CABTREO (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, Not for Oral, Ophthalmic or Intravaginal Use, Rx Only, Net Wt. 50g, Distributed by Bausch Health US, LLC Bridgewater, NJ 08807 USA, Manufactured by: Bausch Health Companies, Inc. Laval Quebec H7L 448, Canada, NDC 0187-0006-25.
Package NDCs: 0187-0006-10; 0187-0006-25; 0187-0006-35		CGMP Deviations: Product was stored outside labeled storage temperature requirements. Product was exposed to controlled room temperature environment instead of remaining refrigerated.MCKESSON CORPORATION / 42 unitsClass IIOngoing
D-0348-202402-12-2024Clobazam Tablets 10mg, 100-count bottle, Rx Only, Manufactured by: Micro Labs Limited Goa-403 722, India. Manufactured for: Micro Labs USA, Inc. Somerset, NJ 08873. NDC 42571-315-01
Package NDCs: 42571-315-30; 42571-315-90; 42571-315-05; 42571-315-32; 42571-315-11; 42571-315-20; 42571-315-91; 42571-315-01; 42571-316-30; 42571-316-90; 42571-316-32; 42571-316-11; 42571-316-20; 42571-316-91; 42571-316-01		CGMP Deviations: Out of specification for residual solvents.Micro Labs Limited / 24,768 bottlesClass IIOngoing
D-0326-202402-09-2024Fluticasone Propionate Nasal Spray USP 50mcg, 120 Metered Sprays - 16 g net fill, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9, Manufactured for: Apotex Corp Weston, FL 33326. NDC 60505-0829-1
Package NDCs: 60505-0829-1		CGMP Deviations: potential presence of Burkholderia cepacia complexApotex Corp. / 292,752 bottlesClass IIOngoing
D-0388-202402-09-2024Telmisartan Tablets, USP 40mg, Rx Only, 30 Tablets per bottle, Manufactured by: Micro Labs Limited Goa-403 722, INDIA, Manufactured for: Micro Labs USA Inc., Somerset, NJ 08873, NDC 42571-227-30.
Package NDCs: 42571-226-30; 42571-226-90; 42571-226-05; 42571-226-10; 42571-226-32; 42571-226-11; 42571-226-41; 42571-227-30; 42571-227-90; 42571-227-05; 42571-227-10; 42571-227-32; 42571-227-11; 42571-227-41; 42571-228-30; 42571-228-90; 42571-228-05; 42571-228-10; 42571-228-32; 42571-228-11; 42571-228-41		Failed Stability Specifications: Out of specification for blend uniformity.Micro Labs Limited / 118,080 bottlesClass IIOngoing
D-0324-202402-09-2024HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Package NDCs: 0904-6440-61; 0904-6441-61; 0904-6442-61; 0904-6443-10; 0904-6443-61		an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / 8,198 unitsClass IIOngoing
D-0367-202402-09-2024Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Package NDCs: 69076-913-25; 69076-913-02		Failed Dissolution Specifications: results slightly under spec at at 9-months.Stason Pharmaceuticals, Inc. / 54, 131 bottlesClass IIIOngoing
D-0371-202402-07-2024Rocuronium Bromide Injection, Preservative Free, 10 mg / mL, Multiple-Dose Vial 10 mL, Rx only, Mfg: Auromedics Pharma LLC, NDC 55150-226-10
Package NDCs: 55150-225-05; 55150-226-10		cGMP Deviations: Products were stored outside the drug label specifications.Mckesson Medical-Surgical Inc. Corporate Office / 70 vialsClass IIOngoing
D-0372-202402-07-2024Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01cGMP Deviations: Products were stored outside the drug label specifications.Mckesson Medical-Surgical Inc. Corporate Office / 70 vialsClass IIOngoing
D-0373-202402-07-2024Bicillin L-A (Penicillin G Benzathine) 1.2, MMU / 2 mL Injection Prefilled Syringe 2 mL, Rx only, Mfg: Pfizer Pharmaceuticals, NDC 60793-0701-10cGMP Deviations: Products were stored outside the drug label specifications.Mckesson Medical-Surgical Inc. Corporate Office / 70 vialsClass IIOngoing
D-0340-202402-06-2024Acthar Gel (repository corticotropin injection) 400 USP units/5mL (80 USP units/mL), 5mL multiple-dose vial, Rx only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.Mallinckrodt Hospital Products Inc. / 8 vials involved in recall (16,479 vials distributed)Class IIOngoing
D-0343-202402-06-2024Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by VSD Productions, Inc. Las Vegas, NevadaMarketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 7000 boxesClass IOngoing
D-0344-202402-06-2024SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Today the World LLC, Vancouver, WA 98683Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 11500 boxesClass IOngoing
D-0341-202402-06-2024Terlivaz (terlipressin for injection), 0.85mg/vial, Single-Dose Vial, Rx only, Distributed by: Mallinckrodt Hospital Products Inc., Bridgewater, NJ 08807, USA, NDC 43825-200-01
Package NDCs: 43825-200-01		cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.Mallinckrodt Hospital Products Inc. / 421 vials involved in this recall (2,448 vials distributed)Class IIOngoing
D-0345-202402-06-2024Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed by: Natural Herbal Remedies, LLC, Cheyenne, WY 82001, www.getarize.comMarketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.Today The World / 5500 boxesClass IOngoing
D-0337-202402-05-2024Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Package NDCs: 43386-038-60		Labeling: Incorrect or Missing Package InsertLupin Pharmaceuticals Inc. / Class IIOngoing
D-0350-202402-05-2024Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.
Package NDCs: 63304-089-13		Failed Dissolution Specifications: Out of specification for dissolution.SUN PHARMACEUTICAL INDUSTRIES INC / 54,960 bottlesClass IIOngoing
D-0393-202402-05-2024Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.Super Chill Products / 3,573 bottlesClass IOngoing
D-0355-202402-02-2024Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2 tablespoons of WATER. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Rx Only, Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC, Bridgewater, NJ 08807, NDC 68682-991-30.
Package NDCs: 68682-990-30; 68682-991-30; 68682-102-30; 68682-104-30		Subpotent Drug: Out of specification for assayBausch Health Companies, Inc. / 3,600 cartonsClass IIOngoing
D-0320-202402-01-2024HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Package NDCs: 68084-447-11; 68084-447-01		Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.Amerisource Health Services LLC / 2,850 cartonsClass IIIOngoing
D-0346-202402-01-2024TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 oz. (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591 UPC 3 63736 81961 3Chemical Contamination; presence of benzene.Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company / 59,644 cansClass IOngoing
D-0318-202402-01-2024Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.NATCO Pharma Limited / 4260 bottlesClass IIOngoing
D-0351-202401-30-2024Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298Lack of Assurance of SterilityBrassica Pharma Pvt Ltd / 315,842 unitsClass IIOngoing
D-0352-202401-30-2024Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304Lack of Assurance of SterilityBrassica Pharma Pvt Ltd / 355,633 unitsClass IIOngoing
D-0354-202401-30-2024Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
Package NDCs: 71406-124-35; 3714061243		Lack of Assurance of SterilityBrassica Pharma Pvt Ltd / 355,120 unitsClass IIOngoing
D-0353-202401-30-2024CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141Lack of Assurance of SterilityBrassica Pharma Pvt Ltd / 159,334 unitsClass IIOngoing
D-0314-202401-25-2024Febuxostat Tablets, 40 mg, 30 Tablets (3 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-538-21, NDC Unit dose 60687-538-11
Package NDCs: 60687-538-11; 60687-538-21		CGMP DeviationsAmerisource Health Services LLC / 1,932 cartonsClass IIOngoing
D-0338-202401-25-2024Pure Care Foaming Mint Hand Sanitizer 62%, Distributed by: Air Scent International, 290 Alpha Drive, RIDC Industrial Park, Pittsburg, PA 15238 USA, www.airscent.com, NDC 75009-562.CGMP DeviationsAlpha Aromatics / 676 gallonsClass IIOngoing
D-0321-202401-25-2024Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Package NDCs: 0555-9009-80; 0555-9009-42; 0555-9010-79; 0555-9010-58; 0555-9008-79; 0555-9008-67		Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.Teva Pharmaceuticals USA, Inc / 12,916 cartonsClass IIIOngoing
D-0322-202401-25-2024Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Package NDCs: 0555-9012-79; 0555-9012-58		Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.Teva Pharmaceuticals USA, Inc / 19,824 cartonsClass IIIOngoing
D-0336-202401-23-2024Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg/ 250 mL (32 mcg/mL), For Intravenous Infusion Only, 250 mL vial, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015. Made in Ireland. NDC: 0338-0108-20
Package NDCs: 0338-0112-20; 0338-0108-20; 0338-0116-20		Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.Baxter Healthcare Corporation / 13,000 bagsClass IIOngoing
D-0325-202401-22-2024Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride Sterile Syringe for Injection, Concentration: 1 Unit/mL, 2 mL Syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN, Compounded Drug Not for Resale. Office Use Only, NDC 71139-0190-1.Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.IntegraDose Compounding Services LLC / 1,299 syringesClass IIOngoing
D-0329-202401-19-2024Meijer Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000345, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 16 cases/4 pack eachClass IIOngoing
D-0332-202401-19-2024Equate Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, a) 30 drops per bag, item number 20000462, b) 160 drops per bag, item number 20000463, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / a) 1597 cases/ 12 pack each b) 73 cases/4 pack eachClass IIOngoing
D-0289-202401-19-2024Omeza Skin Protectant, Skin Protectant Gel 10*2mL VialsCGMP DeviationsOMEZA LLC / 1210 vialsClass IIOngoing
D-0328-202401-19-2024CVS Health Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 160 drops per bag, item number 20001089, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 78 cases/18 packs eachClass IIOngoing
D-0331-202401-19-2024Family Wellness Cherry Cough Drops Menthol cough suppressant/Oral Anesthetic, 80 drops per bag, item number 20001187, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 46 cases/6 pack eachClass IIOngoing
D-0330-202401-19-2024Kroger Cherry Cough Drops, Menthol cough suppressant/Oral Anesthetic, 200 drops per bag, item number 20000064, Bestco, 288 Mazeppa Road, Mooresville, NC 28115CGMP Deviations: Potential Glass and Silicone particulates in productBestco LLC / 21 cases/4 pack eachClass IIOngoing
D-0288-202401-19-2024Omeza Lidocaine Lavage pain relief oil 10*2mL VIALSCGMP DeviationsOMEZA LLC / 4390 vialsClass IIOngoing
D-0266-202401-18-2024Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 11,400 bottlesClass IIOngoing
D-0263-202401-18-2024Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
Package NDCs: 47335-379-83; 47335-380-83; 47335-600-83		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 1,728 bottlesClass IIOngoing
D-0265-202401-18-2024Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 19,992 bottlesClass IIOngoing
D-0312-202401-18-2024Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78		Misprint on tabletDr. Reddy's Laboratories, Inc. / 59,336 bottlesClass IIIOngoing
D-0268-202401-18-2024Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
Package NDCs: 63304-175-13		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 10,690 bottlesClass IIOngoing
D-0272-202401-18-2024Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 14,568 bottlesClass IIOngoing
D-0267-202401-18-2024Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
Package NDCs: 47335-578-83; 47335-578-81; 47335-578-13; 47335-684-83; 47335-684-81; 47335-684-13; 47335-639-83; 47335-639-81; 47335-639-13; 47335-685-83; 47335-685-81; 47335-685-13; 47335-579-83; 47335-579-81; 47335-579-13		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 9,408 bottlesClass IIOngoing
D-0271-202401-18-2024Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
Package NDCs: 47335-307-88; 47335-307-13; 47335-308-88; 47335-308-13		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 1220 bottlesClass IIOngoing
D-0273-202401-18-2024Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
Package NDCs: 51660-998-30; 51660-998-55; 51316-800-90; 51316-800-70; 51316-800-45; 51316-800-30; 51316-800-15; 51316-800-08		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 54,504 bottlesClass IIOngoing
D-0264-202401-18-2024Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
Package NDCs: 47335-721-83; 47335-721-81; 47335-721-13; 47335-722-83; 47335-722-88; 47335-722-18		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 55,272 bottlesClass IIOngoing
D-0313-202401-18-2024Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Package NDCs: 55111-320-30; 55111-320-01; 55111-320-05; 55111-320-79; 55111-320-78; 55111-321-30; 55111-321-01; 55111-321-05; 55111-321-79; 55111-321-78; 55111-322-30; 55111-322-01; 55111-322-05; 55111-322-79; 55111-322-78		Misprint on tabletDr. Reddy's Laboratories, Inc. / 14,425 bottlesClass IIIOngoing
D-0269-202401-18-2024Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.
Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 6552 bottlesClass IIOngoing
D-0270-202401-18-2024Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
Package NDCs: 47335-539-83; 47335-539-81; 47335-539-88; 47335-539-08; 47335-539-18; 47335-614-83; 47335-614-81; 47335-614-88; 47335-614-18; 47335-613-83; 47335-613-81; 47335-613-88; 47335-613-08; 47335-613-18		CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.SUN PHARMACEUTICAL INDUSTRIES INC / 15,768 bottlesClass IIOngoing
D-0342-202401-17-2024Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01
Package NDCs: 42023-159-01; 42023-159-25; 42023-168-01; 0404-9810-01		Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.Henry Schein Inc. and Glove Club HSI Gloves Inc. / 1,099 Single Dose VialsClass IIOngoing
D-0339-202401-16-2024Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Package NDCs: 67877-749-57		Failed Impurities/Degradation Specification: Out of specification for organic impuritiesAscend Laboratories, LLC / 71,244 sachetsClass IIOngoing
D-0286-202401-16-2024OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4.CGMP Deviations: products may not conform to the labeled specifications.Den-Mat Holdings, LLC / 344 tubesClass IIOngoing
D-0287-202401-16-2024Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 59883 00009 7); b) 64 fl. oz. (1.89 L) bottle, NDC 59883-202-64; c) 128 fl. oz. (1 gal) 3.78L bottle, NDC 59883-202-28, UPC 3 59883 00007 3), Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA 93436.CGMP Deviations: products may not conform to the labeled specifications.Den-Mat Holdings, LLC / 10,103 unitsClass IIOngoing
D-0319-202401-15-2024Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd, Oral Solid Dosage Unit, Ahmedabad 382213, India, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 60219-1502-01Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.Amneal Pharmaceuticals of New York, LLC / 858 bottlesClass IIOngoing
D-0334-202401-12-2024Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, Distributed By Neptune Resources, LLC, 30 N. Gould Street, Ste R, Sheridan, WY 82801.Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.Neptune Resources, LLC / 117,000 bottlesClass IOngoing