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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-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-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-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-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 IITerminated
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-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-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-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-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-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-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 IITerminated
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 IITerminated
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 IITerminated
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 IITerminated
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 IITerminated
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-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-0440-202402-15-2024Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial packed 25 vials per carton, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor, NJ 08520, NDC 55150-223-10
Package NDCs: 55150-223-10		Presence of Particulate MatterEugia US LLC / 1,552 10ml x 25/cartonClass IOngoing
D-0349-202402-14-2024Fluticasone Propionate Nasal Spray USP, 50 mcg per spray, 120 metered sprays, 16 g net fill, Rx only, Manufactured by: Apotek Inc., Toronto, Ontario, Cananda, Marketed by: GSMS Incorporated, Camarillo, CA, NDC 60429-195-15
Package NDCs: 60429-195-15		CGMP Deviations:Suspected potential presence of Burkholderia cepacia complexGolden State Medical Supply Inc. / 59,712 bottlesClass 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 IITerminated
D-0470-202402-12-2024ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-count blister card.Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this unapproved drug.FA Online Inc / 400 capsulesClass ITerminated
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-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 IITerminated
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.Failed Stability Specifications: Out of specification for blend uniformity.Micro Labs Limited / 118,080 bottlesClass IITerminated
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 60505-0829-1CGMP Deviations: potential presence of Burkholderia cepacia complexApotex Corp. / 292,752 bottlesClass 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.comFailed Dissolution Specifications: results slightly under spec at at 9-months.Stason Pharmaceuticals, Inc. / 54, 131 bottlesClass IIITerminated
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 0904-6440-61an 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 IITerminated
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 IITerminated
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 IITerminated
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 IITerminated
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-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-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-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 63004-8710-1
Package NDCs: 63004-8710-1; 63004-8710-2; 63004-8712-1; 63004-8712-4; 63004-8711-1; 63004-8711-4		cGMP 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-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-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 ITerminated
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. / N/AClass IITerminated
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-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.Subpotent Drug: Out of specification for assayBausch Health Companies, Inc. / 3,600 cartonsClass IICompleted
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: 68084-447-11Failed 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 IIITerminated
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 IITerminated
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 ICompleted
D-0585-202402-01-2024RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.Integrity Products / 2500 boxesClass IOngoing
D-0586-202402-01-2024To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing a 10-count blister card, Distributed By: Integrity Products, 1710 Fenpark Dr., Fenton, MO 63026Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.Integrity Products / 2500 boxesClass IOngoing
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 371406124356Lack of Assurance of SterilityBrassica Pharma Pvt Ltd / 355,120 unitsClass 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-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-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 IITerminated
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-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 IITerminated
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-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; 0338-0040-20; 0338-0042-20; 0338-0128-20		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-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 IITerminated
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 IITerminated
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 IITerminated
D-0288-202401-19-2024Omeza Lidocaine Lavage pain relief oil 10*2mL VIALSCGMP DeviationsOMEZA LLC / 4390 vialsClass IITerminated
D-0289-202401-19-2024Omeza Skin Protectant, Skin Protectant Gel 10*2mL VialsCGMP DeviationsOMEZA LLC / 1210 vialsClass IITerminated
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 IITerminated
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 IITerminated
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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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-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-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 IICompleted
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 IICompleted
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 IICompleted
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 IICompleted
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-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-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-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 IITerminated
D-0276-202401-12-2024Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30Failed Dissolution SpecificationsGolden State Medical Supply Inc. / 108 bottlesClass IITerminated
D-0335-202401-12-2024Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wide Awake, 3000 mg (150 mg Per Tablet), 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 / 4,932 boxesClass IOngoing
D-0333-202401-12-2024Neptune's Fix, Tianeptine Elixir, Fast Acting, 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 / 1,000,000 bottlesClass IOngoing
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
D-0258-202401-12-2024Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1Subpotent DrugIntegraDose Compounding Services LLC / 281 syringesClass IIOngoing
D-0232-202401-11-2024Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, For Intravenous Infusion, Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977. NDC: 42023-237-10
Package NDCs: 42023-164-01; 42023-164-25; 42023-164-10; 42023-190-01; 42023-219-01; 42023-219-10; 42023-237-01; 42023-237-10; 42023-268-01; 42023-268-10		Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.Par Sterile Products LLC / 1721 cartonsClass IIOngoing
D-0285-202401-11-2024Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-575-21; NDC Unit Dose: 60687-575-11Failed Impurities/Degradation Specification.Amerisource Health Services LLC / 1,568 cartonsClass IITerminated
D-0315-202401-10-2024Medline Remedy Clinical TREAT Antifungal Cream, 2% Miconazole Nitrate, Paraben Free, 4 FL OZ (118 mL) tube, Manufactured for Medline Industries, LP Three Lakes Drive, Northfield, IL 60093. NDC: 53329-147-44
Package NDCs: 53329-147-44		Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.MEDLINE INDUSTRIES, LP - Northfield / 1,786 tubesClass IIOngoing
D-0262-202401-10-2024Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Package NDCs: 71839-104-01		Lack of Sterility Assurance: Aseptic process simulation failure.BE PHARMACEUTICALS AG / 22,176 VialsClass IITerminated
D-0275-202401-08-2024Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Package NDCs: 0591-2510-30		Failed Dissolution SpecificationsTeva Pharmaceuticals USA, Inc / 10,672 30-count bottlesClass IIOngoing
D-0284-202401-05-2024Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-659-06
Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-07; 68180-659-01		Subpotent Drug and Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 165,60 bottlesClass IITerminated
D-0283-202401-05-2024Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC 68180-658-06
Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-07; 68180-659-01		Subpotent Drug and Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 15,576 BottlesClass IITerminated
D-0323-202401-04-2024Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Package NDCs: 24338-850-03; 24338-851-03; 24338-852-03; 24338-853-03; 24338-854-03; 24338-855-03; 24338-856-03		Labeling: Label Mix-upAzurity Pharmaceuticals, Inc. / 4,662 bottlesClass ITerminated
D-0259-202401-04-2024Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Package NDCs: 68462-185-56		Failed Excipient Specifications: OOS for assay of Isopropyl AlcoholGlenmark Pharmaceuticals Inc., USA / 38,496 bottlesClass IITerminated
D-0274-202401-03-2024Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Package NDCs: 68180-405-01; 68180-407-03; 68180-407-04; 68180-416-08; 68180-416-11; 68180-423-11; 68180-423-08		Failed Impurities/Degradation SpecificationsLupin Pharmaceuticals Inc. / 4,608 BottlesClass IITerminated
D-0223-202401-02-2024Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-180-15
Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10		Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.Dr. Reddy's Laboratories, Inc. / 38,952 bottlesClass IICompleted
D-0260-202412-29-2023Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Package NDCs: 64380-752-16		Failed Dissolution SpecificationsStrides Pharma Inc. / 396 50-count bottlesClass IITerminated
D-0237-202412-29-2023Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., Parsippany, NJ 07054, NDC 67877-626-90
Package NDCs: 67877-626-90; 67877-626-01; 67877-626-05; 67877-626-06		Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.Ascend Laboratories, LLC / 3,288 bottlesClass IIOngoing
D-0222-202412-29-2023buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Telangana - 502307, INDIA, NDC 16571-862-03
Package NDCs: 16571-862-03; 16571-862-09; 16571-862-50; 16571-862-10; 16571-862-12; 16571-863-03; 16571-863-09; 16571-863-50; 16571-863-10		Presence of Foreign Tablets/CapsulesRising Pharma Holding, Inc. / 47,976 bottlesClass IIOngoing