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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 July 25, 2025 and include a total of 16975 recall reports.

Recall Number Recall Initiation Date Product Description Recall Reason Recall Firm / Quantity Recall Classification Status
D-0016-202509-25-2024Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58cGMP violationsFresenius Kabi Compounding, LLC / 2756 bagsClass IIOngoing
D-0015-202509-25-2024Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58cGMP violationsFresenius Kabi Compounding, LLC / 1631 bagsClass IIOngoing
D-0018-202509-25-2024Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58cGMP violationsFresenius Kabi Compounding, LLC / 1082 bagsClass IIOngoing
D-0023-202509-25-2024Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56cGMP violationsFresenius Kabi Compounding, LLC / 1008 bagsClass IIOngoing
D-0020-202509-25-2024NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58cGMP violationsFresenius Kabi Compounding, LLC / 733 bagsClass IIOngoing
D-0034-202509-25-2024Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
Package NDCs: 69676-0079-3; 69676-0077-9; 69676-0094-9; 8500157360		Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.Denison Pharmaceuticals, LLC / 105,048 bottlesClass IIIOngoing
D-0033-202509-25-2024Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
Package NDCs: 69676-0079-3; 69676-0077-9; 69676-0094-9; 8500157361		Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.Denison Pharmaceuticals, LLC / 72,648 bottlesClass IIIOngoing
D-0001-202509-24-2024Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, India, NDC: 75834-257-01.
Package NDCs: 75834-256-90; 75834-256-01; 75834-256-05; 75834-256-50; 75834-255-90; 75834-255-01; 75834-255-05; 75834-255-50; 75834-257-90; 75834-257-50; 75834-257-25; 75834-257-01; 75834-258-90; 75834-258-50; 75834-258-02; 75834-258-01		Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.Nivagen Pharmaceuticals Inc / 2328 bottlesClass IIOngoing
D-0006-202509-24-2024Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikma Specialty USA Inc., Columbus, OH 43328, hikma, Glenmark Specialty SA. NDC 59467-700-27.
Package NDCs: 59467-700-27; 59467-700-84		Defective Delivery System: The dip tube is clogged causing the spray not to work.Glenmark Pharmaceuticals Inc., USA / 45,504 bottlesClass IIOngoing
D-0011-202509-24-2024Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Package NDCs: 72578-094-01; 72578-094-02; 72578-094-03		CrystallizationVIONA PHARMACEUTICALS INC / 2544 pumpsClass IIOngoing
D-0007-202509-23-2024Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applications, 57 E. Willow Street, NJ 07041, Millburn USA. NDC 69488-0010-61CGMP deviationsAdvanced Accelerator Applications USA, Inc. / 99 dosesClass IIOngoing
D-0005-202509-19-2024Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2
Package NDCs: 61958-2902-2; 61958-2901-2		Presence of Particulate Matter: Presence of glass particle.Gilead Sciences, Inc. / 105,000 vialsClass IOngoing
D-0008-202509-18-2024Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.123Herbals / unknownClass IOngoing
D-0667-202409-18-2024EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-3010-1CGMP deviationsEnviroServe Chemicals Inc. / 120 bottlesClass IIOngoing
D-0012-202509-17-2024Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Package NDCs: 69452-252-87		Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.Bionpharma Inc. / 1,980 bottlesClass ICompleted
D-0664-202409-16-2024Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230667043,Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.AbbVie Inc. / 2,473,563 tubesClass IIOngoing
D-0665-202409-16-2024Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code: 300230312042Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.AbbVie Inc. / 763,426 tubesClass IIOngoing
D-0013-202509-11-2024First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
Package NDCs: 0536-1271-80		Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.Zhejiang Jingwei Pharmaceutical Co., Ltd. / 295,164 tubesClass IIOngoing
D-0116-202509-11-2024Hylenex recombinant (hyaluronidase) injection, 150 USP units/mL, 4x1 mL Single Dose Vials, Rx only, Manufactured for and marketed by Halozyme, Inc., 12390 El Camino Real San Diego California 92130, Distributed by Antares Pharma, Inc., Ewing, NJ NDC 18657-117-04
Package NDCs: 18657-117-01; 18657-117-02; 18657-117-04; 1000008319; 1000008206; 1000008205		cGMP Deviations: Temperature excursionMckesson Medical-Surgical Inc. Corporate Office / 5 cartons/20 units each cartonClass IICompleted
D-0661-202409-11-2024Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bottle, Rx only, MFG: Bausch & Lomb, NDC 24208-730-06
Package NDCs: 24208-730-06		Temperature abuse: Products exposed to improper temperature above drug label specifications.Mckesson Medical-Surgical Inc. Corporate Office / 27 bottlesClass IITerminated
D-0663-202409-05-2024Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.Lack of Assurance of SterilityEmpower Pharmacy / 450Class IITerminated
D-0662-202409-03-2024Vivier Sheer SPF 30 Mineral With Antioxidants (titanium dioxide 10% and zinc oxide 8%) packaged in 60 ml/2 fl oz, Vivier Canada Inc. / Mfd. for Vivier Pharma, Vaudereull-Dorion OC Canada, J7V 5V5, Champlain, NY USA 12919, Made in Canada, NDC 67226-2232-6. SKU 10-160-ZZ-80059-R
Package NDCs: 67226-2232-6		Microbial Contamination of Non-Sterile ProductVivier Pharma, Inc. / 3476 unitsClass IIOngoing
D-0668-202409-03-2024Mycophenolic Acid Delayed-Release Tablets USP, 360 mg, Rx Only, 120 Tablets per bottle, Manufactured by Alkem Laboratories, LTD, INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-427-12.
Package NDCs: 67877-426-12; 67877-426-05; 67877-426-33; 67877-426-38; 67877-427-12; 67877-427-05; 67877-427-33; 67877-427-38		Failed Dissolution SpecificationsAscend Laboratories, LLC / 117,493 bottlesClass IIOngoing
D-0660-202408-30-2024Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, 07430, NDC 68462-180-22.
Package NDCs: 68462-180-22		Subpotent DrugGlenmark Pharmaceuticals Inc., USA / 2,031,480 ointmentsClass IIOngoing
D-0657-202408-28-2024BARRIER THERAPY SKIN PROTECTANT CREAM (1% colloidal oatmeal), 10 FL OZ/296 ML- tube, Distributed By: Prequel, LOS ANGELES, CA 90069. UPC 8 10129 11007 4Microbial contamination of non-sterile Products -PREQUEL SKIN / 30,946 tubesClass IIOngoing
D-0659-202408-24-2024AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01
Package NDCs: 72888-047-01; 72888-048-01		DiscolorationRubicon Research Private Limited / 3,984 bottlesClass IIIOngoing
D-0654-202408-22-2024Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compounded Rx Product, ProRX 267-565-7008, NDC 84139-225-02Lack of Assurance of SterilityProRx LLC / 500 vialsClass IIOngoing
D-0651-202408-22-2024Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01Lack of Assurance of SterilityProRx LLC / 37 vialsClass IIOngoing
D-0655-202408-22-2024TIRZEPATIDE 20 mg/2mL (10/mg/mL), Rx Only, 2mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-01Lack of Assurance of SterilityProRx LLC / 1,489 vialsClass IIOngoing
D-0656-202408-22-2024TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02Lack of Assurance of SterilityProRx LLC / 1,732 vialsClass IIOngoing
D-0652-202408-22-2024SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01Lack of Assurance of SterilityProRx LLC / 8,396 vialsClass IIOngoing
D-0653-202408-22-2024SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04Lack of Assurance of SterilityProRx LLC / 1,960 vialsClass IIOngoing
D-0650-202408-22-2024Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01Lack of Assurance of SterilityProRx LLC / 2,490 vialsClass IIOngoing
D-0648-202408-21-2024Cefixime for Oral Suspension USP, 100 mg/5 mL, 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		Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.Lupin Pharmaceuticals Inc. / 4554 bottlesClass IITerminated
D-0658-202408-20-2024Just Right 5000, 1.1% Sodium Fluoride, Candy Apple Flavor, Net Wt. 3.4oz (97g), Rx Only, Manufactured for Elevate Oral Care, LLC in the U.S.A with imported pump, 346 Pike Rd, Suite 5, West Palm Beach, FL 33411, NDC 57511-002-1LABELING: LABEL MIX-UP.Elevate Oral Care / Class IIIOngoing
D-0636-202408-15-2024Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th St, N. Wichita, KS 57226.Lack of Assurance of SterilityFagron Compounding Services / Class IIOngoing
D-0113-202508-15-2024Varithena (polidocanol injectable foam) Administration Pack, Contains: 3 silicone-free syringes, 2 compression pads, 1 Varithena Transfer Unit, 1 manometer tubing, Rx Only, Distributed by Biocompatibles Inc., a BTG International Group company. CN01114.3Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).Biocompatibles UK, Ltd. / 432 administration packsClass IIITerminated
D-0642-202408-12-2024Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15		Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.FDC Limited / 176,784 bottlesClass IIOngoing
D-0041-202508-09-2024Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.Direct Rx / 1410 bottlesClass IIOngoing
D-0647-202408-08-2024Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.Failed Impurities/Degradation Specifications - at 18-month Stability testingPreferred Pharmaceuticals, Inc. / 266 bottlesClass IIOngoing
D-0637-202408-08-2024Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales, PA 19454, NDC 0591-2925-30. Packet NDC # 0591-2925-32 Carton NDC # 0591-2925-30
Package NDCs: 0591-2924-18; 0591-2925-32; 0591-2925-30; 0591-2926-25; 0591-2926-30		Superpotent DrugTeva Pharmaceuticals USA, Inc / 7,080 unit dose packetsClass IIOngoing
D-0633-202408-07-2024Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.Taro Pharmaceuticals U.S.A., Inc. / 96 vialsClass IIICompleted
D-0644-202408-06-2024IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tablets per bottle.
Package NDCs: 55111-682-09; 55111-682-01; 55111-682-05; 55111-683-30; 55111-683-50; 55111-683-09; 55111-683-01; 55111-683-05; 55111-684-30; 55111-684-50; 55111-684-60; 55111-684-09; 55111-684-01; 55111-684-05		Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Dr. Reddy's Laboratories, Inc. / 103,298 bottlesClass IIOngoing
D-0645-202408-06-2024IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablets per bottle.
Package NDCs: 55111-682-09; 55111-682-01; 55111-682-05; 55111-683-30; 55111-683-50; 55111-683-09; 55111-683-01; 55111-683-05; 55111-684-30; 55111-684-50; 55111-684-60; 55111-684-09; 55111-684-01; 55111-684-05		Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Dr. Reddy's Laboratories, Inc. / 31,802 bottlesClass IIOngoing
D-0646-202408-06-2024IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tablets per bottle.
Package NDCs: 55111-682-09; 55111-682-01; 55111-682-05; 55111-683-30; 55111-683-50; 55111-683-09; 55111-683-01; 55111-683-05; 55111-684-30; 55111-684-50; 55111-684-60; 55111-684-09; 55111-684-01; 55111-684-05		Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.Dr. Reddy's Laboratories, Inc. / 14940 bottlesClass IIOngoing
D-0640-202408-05-2024HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4x1 gallon jugs), b) 18.92L (5-gallon pail), c) 208.19L (55-gallon drum), and d) 1040.98L (275-gallon tote), ZEE Company 3401 Cummings Road, Chattanooga, TN, 37419, NDC 86161-210CGMP Deviations: sterile water not used for productionZeco LLC / Class IIOngoing
D-0639-202408-05-2024Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-gallon drum), Sold by: ZEE Company- A Member of the Vincit Group, 3401 Cummings Road, Chattanooga, TN 37419, Made in USA.CGMP Deviations: sterile water not used for productionZeco LLC / 604Class IIOngoing
D-0630-202408-02-2024Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064Lack of Assurance of SterilityEMPOWER CLINIC SERVICES LLC / 2,797Class IITerminated
D-0649-202408-01-2024Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Package NDCs: 0338-0431-03; 0338-0433-04; 0338-0424-18; 0338-0428-12		Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.Baxter Healthcare Corporation / 44,208 containersClass IOngoing
D-0629-202408-01-2024Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Package NDCs: 69238-1423-6; 69238-1423-1		Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.Amneal Pharmaceuticals, LLC / 12,624 bottlesClass IIIOngoing
D-0643-202407-31-2024Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bottle (NDC 68462-325-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2 Phase-2, Pharma Zone, SEZ, Pithampur, Dist-Dhar, Madya Pradesh - 454775, India Mfg Llc. No: 25/9/2010, Manufactured for Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430.
Package NDCs: 68462-325-60; 68462-325-90; 68462-325-01; 68462-325-05; 68462-325-10		Failed Dissolution Specifications: below specification resultsGlenmark Pharmaceuticals Inc., USA / 2404 bottlesClass IIOngoing
D-0634-202407-31-2024Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA NDC 70010-227-05
Package NDCs: 70010-227-01; 70010-227-05; 70010-228-01; 70010-228-05		Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin TabletsGranules Pharmaceuticals Inc. / 11,808 500-count BottlesClass IITerminated
D-0624-202407-26-2024Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC, E Windsor, NJ 08520, NDC 55150-306-10.
Package NDCs: 55150-306-10		Presence of Particulate Matter: Complaint received of a glass particle in the vial.Eugia US LLC / 17136 vialsClass IIOngoing
D-0638-202407-24-20240.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.
Package NDCs: 0264-7800-09		Presence of Particulate MatterB. Braun Medical Inc / 63,444 containersClass IOngoing
D-0623-202407-23-2024Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India.
Package NDCs: 69315-308-02; 69315-308-05; 69315-308-10		Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.FDC Limited / 66,528 bottlesClass IIOngoing
D-0621-202407-22-2024Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.
Package NDCs: 68462-626-52		CGMP DeviationsGlenmark Pharmaceuticals Inc., USA / 14,004 cartonsClass IIOngoing
D-0627-202407-18-2024Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in IndiaLabel mix-up: Carton incorrectly labeled.Granules Consumer Health Inc. / 21,192 BottlesClass IIIOngoing
D-0626-202407-18-2024Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.MAIN PRODUCTS INC / 57, 340 bottlesClass IOngoing
D-0632-202407-18-2024Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, [NDC 64980-514-05].
Package NDCs: 64980-513-05; 64980-513-01; 64980-513-15; 64980-514-05; 64980-514-01; 64980-514-15		Defective container; yellow colored spike from cap lodged in the nozzleFDC Limited / 362,544 bottlesClass IIOngoing
D-0620-202407-12-2024Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.SoloVital / 1,331 bottlesClass IOngoing
D-0003-202507-12-2024Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.Supercore Products Group Inc. / 729Class IOngoing
D-0004-202507-12-2024Gold Hard Steel Plus Liquid, 2 FL OZ bottles, UPC 787188873199Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.Supercore Products Group Inc. / 615Class IOngoing
D-0641-202407-11-2024Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distributed by: Aurohealth LLC, 279 Princeton-Hightstown Road, East Windsor, NJ , Made in India, NDC 58602-882-21.
Package NDCs: 58602-882-21; 58602-882-38		Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.Aurobindo Pharma USA Inc / 240 bottlesClass IOngoing
D-0622-202407-10-2024Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 tablets each), Rx Only, Distributed by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC# 49884-306-02.
Package NDCs: 49884-306-02; 49884-307-02; 49884-308-02; 49884-309-02; 49884-310-02		Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.Endo Pharmaceuticals, Inc. / 8,139 cartonsClass ICompleted
D-0597-202407-09-2024Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.
Package NDCs: 57664-231-88; 57664-231-18; 57664-232-88; 57664-232-18; 57664-233-88; 57664-233-18		Failed Dissolution SpecificationsSUN PHARMACEUTICAL INDUSTRIES INC / 5752 bottlesClass IIOngoing
D-0635-202407-08-2024Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Manufactured by: Hikma Farmaceutica (Portugal), SA, distributed by Hikma Pharmaceuticals USA Inc Berkeley Heights, NJ NDC 0143-9386-01
Package NDCs: 0143-9386-01; 0143-9386-10		Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)Hikma Pharmaceuticals USA Inc. / 31,400 bagsClass IOngoing
D-0594-202407-03-2024Lidocaine HCL Injection, USP 2% 200mg/10mL (20mg/mL) and EPINEPHRINE HCl 1:200,000, 10 ml Single Dose Vial, Rx only, Compounded drug by Medivant Healthcare, 158 S Kyrene Rd, Chandler, AZ 85226, NDC 81483-0038-0, UPC 3 81483 00380 2Subpotent Drug: reduced efficacy for epinephrineTAILSTORM HEALTH INC / 12,525 10 mL vialsClass IIOngoing
D-0595-202407-02-2024Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1725-01 (vial), NDC 70710-1725-06 (outer box).Cross contamination with other productsZydus Pharmaceuticals (USA) Inc / 12720 vialsClass IIIOngoing
D-0582-202407-02-2024Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotoxic Agent, Sterile, Rx Only, Single-Dose Vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 47335-361-40.CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltered bulk for decitabine for injection.SUN PHARMACEUTICAL INDUSTRIES INC / 2088 vialsClass IIOngoing
D-0596-202407-02-2024Micafungin for injection, USP, 100 mg/vial, Single-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Vadodara, India, NDC 16714-301-01 (vial), NDC 16714-301-10 (outer box).
Package NDCs: 16714-164-01; 16714-164-10; 16714-301-01; 16714-301-10		Cross contamination with other productsZydus Pharmaceuticals (USA) Inc / n/aClass IIIOngoing
D-0593-202407-02-2024Verapamil Hydrochloride Injection, USP 10 mg/4 mL (2.5 mg/mL), 5 x 4 mL Single-Dose Vial per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534, Vial NDC: 70710-1644-1, Carton NDC: 70710-1644-5.
Package NDCs: 70710-1643-5; 70710-1643-7; 70710-1644-1; 70710-1644-5		Cross contamination with other products.Zydus Pharmaceuticals (USA) Inc / 8020 vialsClass IIIOngoing
D-0592-202407-02-2024Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
Package NDCs: 70710-1643-5; 70710-1643-7; 70710-1644-1; 70710-1644-5; 70710-1643-1		Cross contamination with other products.Zydus Pharmaceuticals (USA) Inc / 170,755 vialsClass IIIOngoing
D-0628-202407-02-2024PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100g/7.5 g /2.691 g/1.015 g/ 5.9 g / 4.7 g, 3 pouches/carton, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC# 0093-3560-26.
Package NDCs: 0093-3560-19; 0093-3560-26; 0093-9044-19; 0093-9043-19		Defective container: potential for non-sealed pouches which can lead to product leakage.Novel Laboratories, Inc. d.b.a Lupin Somerset / 13,200 cartonsClass IIITerminated
D-0612-202406-28-2024Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-198-05, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430,
Package NDCs: 68462-195-90; 68462-195-05; 68462-196-90; 68462-196-05; 68462-197-90; 68462-197-05; 68462-198-90; 68462-198-05		Failed Dissolution Specifications: results below specificationsGlenmark Pharmaceuticals Inc., USA / a) 145,800 bottles; b) 1,368 bottlesClass IIOngoing
D-0601-202406-28-2024Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada By: Patheon, Inc., Mississauga, ON, Canada L5N 7K9, Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0997-02.
Package NDCs: 0555-0997-02		Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification limits.Teva Pharmaceuticals USA, Inc / 116,144 bottlesClass IIOngoing
D-0600-202406-27-2024Cyanocobalamin Injection, USP, 1,000mcg/mL, 1 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN, 38141, Mfd. in India, NDC 16714-165-01.Presence of particulate matter: glassZydus Pharmaceuticals (USA) Inc / 432250 vialsClass IIOngoing
D-0666-202406-26-2024Infla-650 Herbal Dietary Supplement, 700mg, packaged in pouches containing 60 capsules, Distributed by: Guru Inc., 4370 Lawrenceville Hwy NW, P.O. Box 2204, Lilburn, GA 30047-1100, USA. Ph.: 872 216 1566, http://www.dalayurevda.com, Made in India, UPC: 042535355019Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.Guru Inc. / Class IIOngoing
D-0591-202406-26-2024Blemfree All Day Lotion (salicylic acid 0.5% w/w), packaged in a) 1 oz. 29 ML tube NDC:53228-003-01 b) 4 OZ 118ML plastic bottle, UPC 7 01450 90008 6, NDC # 53228-002-01, Equibal Labs, IncCGMP Deviations: Manufactured without following Current Good Manufacturing Practises.Equibal Inc / 90/1 oz. tubes and 248/4 oz. bottlesClass IICompleted
D-0625-202406-26-2024Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90
Package NDCs: 43598-478-01; 43598-478-90; 43598-479-01; 43598-479-90		Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packetsDr. Reddy's Laboratories, Inc. / 5,136 cartonsClass IIIOngoing
D-0611-202406-26-2024Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-1203-03CGMP Deviations: Out of specification for dissolutionRemedyRepack Inc. / 142 blister cards, 30 per blister cardClass IITerminated
D-0570-202406-26-2024Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.CGMP Deviations and Presence of Particulate Matter: GlassMedisca Inc. / 113 bottlesClass IICompleted
D-0615-202406-25-2024Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.GLOBAL WIDGET LLC / 11130 bottlesClass IIIOngoing
D-0614-202406-25-2024Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.GLOBAL WIDGET LLC / 2466 bottlesClass IIIOngoing
D-0613-202406-25-2024Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2
Package NDCs: 73423-003-01		Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.GLOBAL WIDGET LLC / 18540 bottlesClass IIIOngoing
D-0619-202406-25-2024Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-count bottle (NDC 68001-396-03), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Distributed by: Dhar, Madhya Pradesh 454 775, India. Distributed for: BluePoint Laboratories.
Package NDCs: 68001-396-00; 68001-396-03		Failed Dissolution SpecificationsAmerisource Health Services LLC / 61,231 bottlesClass IOngoing
D-0616-202406-25-2024Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.GLOBAL WIDGET LLC / 2082 bottlesClass IIIOngoing
D-0599-202406-24-2024Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Package NDCs: 64980-124-15; 64980-124-03; 64980-124-45; 64980-124-60		Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.Rising Pharma Holding, Inc. / 868 tubesClass IIIOngoing
D-0569-202406-24-2024SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.
Package NDCs: 13709-325-01		Sub-potent DrugNeilmed Pharmaceuticals Inc / 20,370 bottlesClass IIIOngoing
D-0590-202406-24-2024buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01.
Package NDCs: 60687-782-11; 60687-782-01; 60687-793-11; 60687-793-21		Failed Dissolution Specifications; the product is dissolving faster than the specified limits.Amerisource Health Services LLC / 2,484 cartonsClass IIOngoing
D-0631-202406-21-2024Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyville, IL 60048. NDC: 50090-5313-2
Package NDCs: 50090-5313-1; 50090-5313-2; 50090-5313-3; 50090-5313-4; 50090-5313-5		Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.A-S Medication Solutions LLC / 429 bottlesClass ITerminated
D-0617-202406-21-2024Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Package NDCs: 68382-034-06; 68382-034-16; 68382-034-10; 68382-035-06; 68382-035-16; 68382-035-10; 68382-036-06; 68382-036-16; 68382-036-10		Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.Zydus Pharmaceuticals (USA) Inc / a) 13,128 bottles; b) 252 bottlesClass IICompleted
D-0572-202406-20-2024Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 788 glass jarsClass IIOngoing
D-0576-202406-20-2024Little Moon Essentials, Ass Kisser, Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88228 2, NDC 70722-208-05; b) 3 OZ (85.05G) metal tin, UPC Code 6 73673 88208 4, NDC 70722-208-03; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 165 metal tinsClass IIOngoing
D-0575-202406-20-2024Little Moon Essentials, Vital Vapor Balm, (Camphor 0.6%, Menthol 5.2%) Packaged as a) 0.5OZ (14G) metal tin, UPC Code 6 73673 88231 2, NDC 70722-229-05) b) 2OZ (57G) glass jar, UPC Code 6 73673 88220 6, NDC 70722-229-02; c) 4OZ (113G) glass jar, UPC Code 6 73673 88218 3, NDC 70722-229-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1041Class IIOngoing
D-0577-202406-20-2024Little Moon Essentials, Asana Kisser, (Camphor 1.35%, Menthol 2.86%), Packaged as a) 0.5 OZ (14G) metal tin, UPC Code 6 73673 88227 5, NDC 70722-216-05; b) 3 OZ (85-05G) metal tin UPC Code 6 73673 88216 9, NDC 70722-216-03; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 320 metal tinsClass IIOngoing
D-0571-202406-20-2024Little Moon Essentials, Magical Muscle Oil, (Camphor 1.95%, Menthol 3.75%) packaged as: a) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88202 2, NDC 70722-246-02; b) 4 FL OZ (118ML) jar, UPC Code 6 73673 88233 6, NDC 70722-246-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1654 glass jarsClass IIOngoing
D-0574-202406-20-2024Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 1264 glass jarsClass IIOngoing
D-0573-202406-20-2024Little Moon Essentials, Aching Head Rub (Camphor 3.09%, Menthol 2.55%) , a) 0.5OZ (14G), metal tin, UPC Code 67367388226 8, NDC 70722-203-05; b)1OZ (28G) glass jar, UPC Code 6 73673 88203 9, NDC 70722-203-01; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 6,312 tin and glass jarsClass IIOngoing
D-0578-202406-20-2024Little Moon Essentials, Clear Breeze Plus, Hand Sanitizer (Alcohol 65% v/v) Packaged as a) 2 FL OZ (60ML) spray bottle, UPC Code 6 73673 88797 3, NDC 70722-319-02; b) 4 FL OZ (118ML) spray bottle, UPC Code 6 73673 88798 0, NDC 70722-319-04; Little Moon Essentials LLC Dania Beach, Fl 33004CGMP deviationsLittle Moon Essentials LLC / 20 spray bottlesClass IIOngoing
D-0608-202406-18-2024DELFLEX PERITONEAL DIALYSIS SOLUTION With LOW MAGNESIUM / LOW CALCIUM 4.25% DEXTROSE and attached stay "safe Exchange Set, 2500mL (Approx. 50 mL excess), Single Dose Container Sterile and Non-Pyrogenic, For Intraperitoneal Administration Only, Fresenius Medical Care NA Waltham, MA 02451, 1-800-323-5188 NDC 49230-212-94
Package NDCs: 49230-206-92; 49230-206-94; 49230-206-95; 49230-209-92; 49230-209-94; 49230-209-95; 49230-212-92; 49230-212-94; 49230-212-95		This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.Fresenius Medical Care Holdings, Inc. / 183 casesClass IIOngoing