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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0991-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0425-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 24 bags | Class II | Terminated |
| D-1036-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, IV Bag, total volume = 810 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0103-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 88 bags | Class II | Terminated |
| D-0995-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0402-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-1014-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 6%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0423-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-0964-2023 | 07-14-2023 | phenylephrine 50 mg added to 0.9% sodium chloride 250mL, CONCENTRATION = 200mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 472 bags | Class II | Terminated |
| D-0998-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 420 bags | Class II | Terminated |
| D-0965-2023 | 07-14-2023 | PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 499,304 Syringes | Class II | Terminated |
| D-0981-2023 | 07-14-2023 | heparin 7500 units added to 0.9% sodium chloride 1000mL, CONCENTRATION = 7.5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7009-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 448 bags | Class II | Terminated |
| D-0959-2023 | 07-14-2023 | EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7019-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 4,570 bags | Class II | Terminated |
| D-1023-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 7.5 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 238.75 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0007-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 56 bags | Class II | Terminated |
| D-0960-2023 | 07-14-2023 | PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1. | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 7518 bag | Class II | Terminated |
| D-0990-2023 | 07-14-2023 | potassium phosphate, 30 mmole added to 0.9% sodium Chloride 500mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7016-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 234 bags | Class II | Terminated |
| D-1011-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 420 bags | Class II | Terminated |
| D-0992-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0401-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 48 bags | Class II | Terminated |
| D-1007-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with CALCIUM, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043,NDC: 72196-0407-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 156 bags | Class II | Terminated |
| D-0993-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0416-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 188 bags | Class II | Terminated |
| D-0989-2023 | 07-14-2023 | potassium phosphate 15 mmole added to 0.9% sodium Chloride 250 mL, IV Bag, RX Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6060-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 7469 bags | Class II | Terminated |
| D-1016-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION 40 mEq K, Warm Induction 4:1 High Potassium, IV Bag, total volume = 500mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0002-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-0950-2023 | 07-14-2023 | vancomycin 1.25 g/250 mL added to dextrose 5%, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix AZ 85043, NDC: 72196-6073-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 4824 bags | Class II | Terminated |
| D-1025-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, LEESBURG CARDIOPLEGIA, IV Bag, Total Volume = 1030.2 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0218-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 36 bags | Class II | Terminated |
| D-1005-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 304 bags | Class II | Terminated |
| D-0988-2023 | 07-14-2023 | norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC 72196-8095-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags | Class II | Terminated |
| D-1013-2023 | 07-14-2023 | oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 2692 bags | Class II | Terminated |
| D-1029-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 106 mEq K, Modified St. Thomas Solution High Potassium High Sodium Bicarbonate, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0204-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 144 bags. | Class II | Terminated |
| D-0983-2023 | 07-14-2023 | oxyTOCIN, 20 units added to dextrose 5%/lactated ringers 1000 mL, IV Bag, Rx Only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6031-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 463 bags | Class II | Terminated |
| D-1026-2023 | 07-14-2023 | TRANSPLANT SOLUTION, Plasma-Lyte A - 75 ml, MSA/MSG 0.92 Molar -60 ml, dextrose 70% 21.3 ml; IV Bag, Total Volume = 165 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0014-2 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 12 IV bags | Class II | Terminated |
| D-0986-2023 | 07-14-2023 | oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, This drug was repacked by CAPS, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 130,250 bags | Class II | Terminated |
| D-1006-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3.5%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 108 bags | Class II | Terminated |
| D-1040-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, IV Bag, total volume = 500 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 72 bags | Class II | Terminated |
| D-1002-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0413-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 96 bags | Class II | Terminated |
| D-0955-2023 | 07-14-2023 | vancomycin 1.25 g/250 mL added to 0.9% Sodium Chloride, 5 mg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6074-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 15,304 bags | Class II | Terminated |
| D-0996-2023 | 07-14-2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 296 bags | Class II | Terminated |
| D-0956-2023 | 07-14-2023 | Cardioplegia Solution del Nido Formula, IV Bag, Total Volume = 1,052.8 mL, FOR INTRACARDIAC PERFUSION USE ONLY, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Approx. Osmolarity 386 mOsm/L, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 10,480 bags | Class II | Terminated |
| D-1033-2023 | 07-14-2023 | CARDIOPLEGIA SOLUTION, 70 mEq K, Modified St. Thomas Formula low potassium, IV Bag, Total Volume = 1000 mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0210-1 | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. / 80 bags. | Class II | Terminated |
| D-0940-2023 | 07-13-2023 | Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bottle, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries Inc., Cranbury, NJ 08512, NDC 57664-230-88. Package NDCs: 57664-228-83; 57664-228-88; 57664-228-08; 57664-228-13; 57664-228-18; 57664-229-83; 57664-229-88; 57664-229-08; 57664-229-13; 57664-229-18; 57664-230-83; 57664-230-88; 57664-230-08; 57664-230-13; 57664-230-18 | Presence of Foreign Substance: Metal embedded in a tablet. | SUN PHARMACEUTICAL INDUSTRIES INC / 7313 bottles | Class II | Terminated |
| D-0944-2023 | 07-13-2023 | Testosterone Cypionate-Testosterone Propionate 180-20 mg/mL in cottonseed oil, Compounded Rx, For Intramuscular Use Only, a) 1 mL, b) 5 mL Multi-Dose Vial, New Vitalis Pharmacy, 4139 Cadillac Ct, Ste 201, Louisville, KY 40213 | Lack of Assurance of Sterility | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy / 102 vials | Class II | Ongoing |
| D-0936-2023 | 07-11-2023 | Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 65,710 vials for 1 g and 2 g strength | Class II | Ongoing |
| D-0937-2023 | 07-11-2023 | Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 760 bottles | Class II | Ongoing |
| D-0925-2023 | 07-11-2023 | Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-476-30. Package NDCs: 67877-476-56; 67877-476-33; 67877-476-32; 67877-476-14; 67877-476-58; 67877-476-30 | Failed Dissolution Specifications | Ascend Laboratories, LLC / 2652 bottles | Class II | Ongoing |
| D-0935-2023 | 07-11-2023 | Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10. | Lack of Assurance of Sterility | Sagent Pharmaceuticals / 65,710 vials for 1 g and 2 g strength | Class II | Ongoing |
| D-0929-2023 | 07-10-2023 | Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 500 mL, 500 mL IV Bag (515 total volume), Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC 71546-310-50; | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 209 Bags | Class II | Terminated |
| D-0928-2023 | 07-10-2023 | ROcuronium Bromide 50 mg/5 mL ( 10 mg/mL), 5mL Syringe, RX Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-090-05 | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 500 Syringes | Class II | Terminated |
| D-0927-2023 | 07-10-2023 | PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042, NDC: 71546-450-25; | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 82 Bags | Class II | Terminated |
| D-0914-2023 | 07-10-2023 | Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India. NDC#: 62756-200-83 Package NDCs: 62756-200-83; 62756-200-18; 62756-224-83; 62756-224-88; 62756-224-08; 62756-224-18 | Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing | SUN PHARMACEUTICAL INDUSTRIES INC / 8,880 30-count bottles | Class II | Terminated |
| D-0926-2023 | 07-10-2023 | SUCCINYLcholine Chloride 200 mg/10mL (20 mg/mL), 10 mL BD Syringe, Rx Only, Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, MA 01801-1042; NDC: 71546-083-10 | CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production. | New England Life Care, Inc. dba Advanced Compounding Solutions / 493 syringes | Class II | Terminated |
| D-0915-2023 | 07-10-2023 | Big Machine Distillery Hand Sanitizer Non-Sterile Solution Alcohol Antiseptic 80% Topical Solution, Produced and Distributed by Big Machine Distillery 1800 Abernathy Road Lynnville, TN 38472 a) 50 mL UPC 8 59105 00452 5; b) 100 mL UPC 8 59105 00453 2; c) 375 mL; d) 1/2 gallon; e) 1 gallon; f) 5 gallon; g) 55 gallon; i) Indianapolis Motor Speedway 50 mL UPC 8 59105 00452 5; j) Indianapolis Motor Speedway 375 mL UPC 8 59105 00454 9; k) Indianapolis Motor Speedway 1 gallon UPC 8 59105 00451 7; l) The Contributor 50 mL; m) Tony Kanaan Last Lap 100 mL; n) Tony Kanaan Last Lap 375 mL; o) Trexis Insurance 50 mL; p) Team Penske 50 mL; q) Middle Tennessee State University Lightning 50 mL. | CGMP Deviation: impurities exceed allowable limits. | Tenn South Distillery LLC dba Big Machine Distillery / 540 gallons | Class II | Ongoing |
| D-0931-2023 | 07-07-2023 | Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-552-01. | Lack of Assurance of Sterility | SterRx, LLC / 132,299 bags | Class II | Terminated |
| D-0934-2023 | 07-07-2023 | Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-702-01. | Lack of Assurance of Sterility | SterRx, LLC / 2,088 bags | Class II | Terminated |
| D-0932-2023 | 07-07-2023 | Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per case, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-577-01. | Lack of Assurance of Sterility | SterRx, LLC / 125,598 bags | Class II | Terminated |
| D-0930-2023 | 07-07-2023 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01. | Lack of Assurance of Sterility | SterRx, LLC / 137,304 bags | Class II | Terminated |
| D-0933-2023 | 07-07-2023 | Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per carton, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-602-01. | Lack of Assurance of Sterility | SterRx, LLC / 92,148 bags | Class II | Terminated |
| D-0913-2023 | 07-05-2023 | Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28 Package NDCs: 0093-8199-28; 0093-8224-28; 0093-8229-28; 0093-8231-28 | Failed Moisture Limits: Water (moisture) content above the approved product specifications. | Teva Pharmaceuticals USA Inc / 180 bottles | Class II | Terminated |
| D-0924-2023 | 07-05-2023 | Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one bottle in a carton in a) 10 mL bottle (NDC# 62756-232-55) and b) 15 mL bottle (NDC # 62756-232-56), Rx only, Distributed by: Sun Pharmaceutical Ind., Inc., NJ 08512, Manufactured by: Sun Pharmaceutical Medicare Ltd., India. Package NDCs: 62756-232-90; 62756-232-55; 62756-232-56 | Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. | SUN PHARMACEUTICAL INDUSTRIES INC / 20,884 cartons | Class III | Terminated |
| D-0916-2023 | 07-05-2023 | 0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA, NDC 0264-5802-00 Package NDCs: 0264-5802-00; 0264-5802-10; 0264-5804-00; 0061858305; 0061858306 | Lack of assurance of sterility: bags have the potential to leak. | B. Braun Medical Inc. / 79,880 bags | Class II | Terminated |
| D-0917-2023 | 07-03-2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43. Package NDCs: 16729-512-05; 16729-512-43 | Presence of Particulate Matter: Particulate matter identified as fiber. | Accord Healthcare, Inc. / 2348 vials | Class II | Terminated |
| D-0918-2023 | 07-03-2023 | Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67. Package NDCs: 16729-275-03; 16729-275-67 | Presence of Particulate Matter: Particulate matter identified as fiber. | Accord Healthcare, Inc. / 1680 vials | Class II | Terminated |
| D-0899-2023 | 06-27-2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 India, NDC 68180-721-03 Package NDCs: 68180-750-09; 68180-751-09; 68180-751-03; 68180-751-17; 68180-752-09; 68180-752-03; 68180-719-03; 68180-719-09; 68180-720-09; 68180-720-03; 68180-721-03; 68180-721-09; 68180-233-01; 68180-233-02; 68180-455-02; 68180-455-01 | Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study. | Lupin Pharmaceuticals Inc. / 3,096 bottles | Class III | Terminated |
| D-0938-2023 | 06-27-2023 | Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60 Package NDCs: 69097-142-60 | Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket). | Cipla USA, Inc. / 278,538 canisters | Class I | Terminated |
| D-0895-2023 | 06-26-2023 | Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108, SIDCO Pharmaceutical Complex, Alathur, Kanchipuram- 603 110, Tamilnadu, India, NDC 64380-933-08 Package NDCs: 64380-933-04; 64380-933-05; 64380-933-08; 64380-934-04; 64380-934-05; 64380-934-08; 64380-935-04; 64380-935-05; 64380-935-08 | Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet. | Strides Pharma Inc. / 2,700 HDPE Bottles | Class II | Terminated |
| D-0894-2023 | 06-26-2023 | Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3), c) 60-count bottles, (NDC: 68788-7781-6), d) 90-count bottles (NDC: 68788-7781-9), e) 120-count bottles (NDC: 68788-7781-8), Rx only, Mfg: Dr. Reddy's Laboratories Limited. Package NDCs: 68788-7781-2; 68788-7781-3; 68788-7781-6; 68788-7781-9; 68788-7781-1; 68788-7781-8 | Failed Stability Specifications | Preferred Pharmaceuticals, Inc. / 541 Bottles | Class II | Ongoing |
| D-0896-2023 | 06-23-2023 | PANCREAZE (pancrelipase) Delayed-Release Capsules, 100-count bottles, Rx only, Rx only, Manufactured by VIVUS LLC, Campbell, CA 95008, UPC: N3 62541-401-10 5, NDC 62541-401-10, Package NDCs: 62541-402-10; 62541-403-10; 62541-404-10; 62541-405-10; 62541-401-10; 62541-406-50; 62541-406-10 | Failed Stability Specifications | Vivus, Inc. / 4240 bottles | Class III | Ongoing |
| D-0892-2023 | 06-23-2023 | Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-645-01 (carton), barcode (01) 003 68084 645 11 2. Package NDCs: 68084-645-11; 68084-645-01; 68084-645-65; 68084-775-95; 68084-775-25 | Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution. | Amerisource Health Services LLC / 4,971 cartons | Class II | Terminated |
| D-1081-2023 | 06-23-2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA Package NDCs: 68180-904-73; 68180-905-74; 68180-910-74; 68180-904-71 | Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test | Lupin Pharmaceuticals Inc. / 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch | Class I | Terminated |
| D-0943-2023 | 06-23-2023 | Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807 | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Kramer Laboratories, Inc. / N/A | Class II | Terminated |
| D-0942-2023 | 06-23-2023 | Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807 | CGMP Deviations: use of non-food grade lubricant in mixing vessel. | Kramer Laboratories, Inc. / N/A | Class II | Terminated |
| D-0941-2023 | 06-22-2023 | Diclofenac Sodium Topical Solution USP, 2% w/w, 3.8 FL.OZ.(112 grams) bottles, Rx only, Manufactured for: Alembic Pharmaceuticals, Inc. Bedminster, NJ 07921, USA Manufactured by: Alembic Pharmaceuticals Limited (Derma Division) Karakhadi, Vadodara 391450, India. NDC 62332-487-12 Package NDCs: 62332-487-12 | Defective Delivery System | ALEMBIC PHARMACEUTICALS, INC. / 2844 units | Class II | Ongoing |
| D-0923-2023 | 06-21-2023 | Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam - 532 409 India. NDC 55111-180-10 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 | Failed dissolution specification: Out of specification results observed in 24-month long term stability testing. | Dr Reddy's Laboratories Limited / 17,548 1000-countbottles | Class II | Ongoing |
| D-0878-2023 | 06-16-2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61 | Packaging defect: blister packaging inadequately sealed. | The Harvard Drug Group / 3876 cartons | Class II | Terminated |
| D-0897-2023 | 06-13-2023 | Original Eye Drops; Redness Reliever; (Tetrahydrozoline HCl), 0.05%, 0.5 FL OZ (15mL); distributed by a) Original Formula Eye Drops, DG health, DISTRIBUTED BY OLD EAST MAIN CO, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 00556 5; b) Publix, DISTRIBUTED BY PUBLIX SUPER MARKETS, INC, 3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811, UPC 0 41415 01076 5; c) sterile eye drops, Original Formula, sunmark, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 16733 0, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELKGROVE VILLAGE, IL 60007, UPC 0 36800 03639 0; e) Eye Drops, Original Formula, GoodSense, Distributed By: Geiss, Destin & Dunn, Inc., Peachtree City, GA 30269, UPC 1 80410 00015 6, NDC 50804-141-01; f) sterile eye drops, Circle K, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404 Proudly distributed by Circle K Stores Inc., UPC 1 94283 65185 8; g) Sterile Eye Drops, Regular Formula, Lil Drug Store, Product manufactured for: Lil' Drug Store Products, Inc., 9300 Earhart Lane SW, Cedar Rapids, IA 52404; UPC 3 66715 68324 3; h) Tetrahydrozoline Ophthalmic Solution, Rugby, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, UPC 3 05361 21794 5, NDC 0536-1217-94, i) Leader, DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017, UPC 0 96295 13645 6, NDC 70000-0454-1; j) REDNESS RELIEF EYE DROPS, CAREone, Distributed by: FOODHOLD USA, LLC, LANDOVER, MD 20785; UPC 0 41520 86531 1, NDC 41520-431-05; k) Eye Drops, Original Formula, Good Neighbor Pharmacy, Distributed By AmerisourceBergen, 1300 Morris Drive, Chesterbrook, PA 19087, UPC 0 87701 14975 7, NDC 24385-075-05; l) Eye Drops, ORIGINAL FORMULA, Walgreens, DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015, UPC 3 11917 20076 7; m) CVS Health, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 36131 3; n) H-E-B, MADE WITH PRIDE & CARE FOR H-E-B, SAN ANTONIO, TX 78204, UPC 0 41220 43747 4; o) redness relief, Original Redness Reliever Eye Drops, meijer, DIST. BY MEIJER DISTRIBUTION INC., GRAND RAPIDS, MI 49544, UPC 0 41250 82916 4, NDC 41250-814-01; p) Eye Drops, ORIGINAL, Best Choice, PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO., 5000 KANSAS AVE, KANSAS CITY, KS 66106, UPC 0 70038 47011 3 Package NDCs: 49348-037-29; 50804-141-01; 41250-814-01; 0536-1217-94; 70000-0454-1; 41520-431-05; 24385-075-05 | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. | K.C. Pharmaceuticals, Inc / 341,568 bottles | Class II | Ongoing |
| D-0898-2023 | 06-13-2023 | Dry Eye Relief Lubricant Eye Drops, (Glycerin 0.2%, Hypromellose 0.2 %, Polyethylene glycol 400 1%), 0.5 FL OZ (15mL) bottle, packaged in a) equate, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716, 2-0.5 FL OZ (15 mL) Bottles, 1 FL OZ (30 mL) TOTAL, UPC 6 81131 36701 1, NDC 49035-280-02; b) DG health, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072, UPC 0 95072 02656 0; c) sunmark, Distributed By McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 10939 62144 3, NDC 49348-037-29; d) TopCare health, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007, UPC 0 36800 36100 3; e) HealthMart, Distributed by McKesson, 6555 State Highway 161, Irving, TX 75039, UPC 0 52569 13715 4; f) exchange select Artificial Tears, Manufactured for your Military Exchanges by: KC Pharmaceuticals, Inc., Pomona, CA 91768, UPC 6 14299 05620 6; g) meijer, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544, UPC 7 13733 29692 2, NDC 41250-718-01; h) H.E.B, MADE WITH PRIDE AND CARE FOR H.E.B, SAN ANTONIO, TX 78204, UPC 0 41220 43741 2; i) GeriCare, Distributed by: Gericare Pharmaceuticals Corp., 1650 63rd St., Brooklyn, NY 11204, UPC 3 57896 18405 6, NDC 57896-181-05 Package NDCs: 49035-280-01; 49035-280-02; 49348-037-29; 41250-718-01; 57896-181-05 | CGMP Deviations: good manufacturing deficiencies related to a lack of documentation of the fill line. | K.C. Pharmaceuticals, Inc / 397,430 bottles | Class II | Ongoing |
| D-0875-2023 | 06-13-2023 | Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13 Package NDCs: 50268-772-11; 50268-772-13 | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | AVKARE LLC / 592 cartons | Class III | Ongoing |
| D-0871-2023 | 06-12-2023 | Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30 Package NDCs: 69918-301-30 | Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. | Amring Pharmaceuticals Inc / 48,989 bottles | Class III | Terminated |
| D-0879-2023 | 06-12-2023 | Endometrin (progesterone) Vaginal Insert 100mg, packaged in a carton of 21 vaginal inserts with 21 disposable vaginal applicators, Manufactured for: Ferring Pharmaceuticals Inc., Parsippany, NJ NDC# 55566-6500-03 | cGMP deviations: potential for Microbial Contamination of Non-Sterile Products | Ferring Pharmaceuticals Inc / N/A | Class II | Terminated |
| D-0870-2023 | 06-06-2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, WA 98275, NDC 51662-1487-3 Package NDCs: 51662-1487-1; 51662-1487-2; 51662-1487-3 | Labeling: Label Mix-up | HF Acquisition Co LLC / 9 boxes of 25 vials | Class III | Terminated |
| D-0888-2023 | 06-05-2023 | StellaLife VEGA Oral Care Spray, 1 fl oz (30 ml) bottles, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-101-02 | cGMP deviations | Homeocare Laboratories, Inc. / 40,034/1 fl. oz tubes | Class II | Terminated |
| D-0885-2023 | 06-05-2023 | SnoreStop Naso Spray Bulk, liquid, Distributed by Green Pharma, NDC 61152-199-99 | cGMP deviations | Homeocare Laboratories, Inc. / 200 liters/55 gallon drum | Class II | Terminated |
| D-0886-2023 | 06-05-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-103-16 Package NDCs: 69685-103-16 | cGMP deviations | Homeocare Laboratories, Inc. / 130,762/16 oz. tottles | Class II | Terminated |
| D-0890-2023 | 06-05-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Peppermint, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-112-01 Package NDCs: 69685-112-01; 69685-115-01; 69685-111-01 | cGMP deviations | Homeocare Laboratories, Inc. / 33,109/1 fl. oz. tubes | Class II | Terminated |
| D-0887-2023 | 06-05-2023 | StellaLife VEGA Oral Care Rinse, 16 fl oz (473 ml) bottles, Coconut, Distributed by: StellaLife, Aventura, FL NDC 69685-113-16 Package NDCs: 69685-113-16 | cGMP deviations | Homeocare Laboratories, Inc. / 16,587 bottles | Class II | Terminated |
| D-0880-2023 | 06-05-2023 | Kanjo Homeopathic Pain Relief Cream With Arnica, NET WT 2 oz (56.70G), Manufactured For: Acutens, Inc., Sheridan, WY NDC 80551-201-02 | cGMP deviations | Homeocare Laboratories, Inc. / 921 bottles | Class II | Terminated |
| D-0889-2023 | 06-05-2023 | StellaLife VEGA Oral Care Gel, 1 fl oz (30 ml) tubes, Distributed by: StellaLife, Inc., Aventura, FL NDC 69685-102-02 | cGMP deviations | Homeocare Laboratories, Inc. / 38,105/1 fl. oz. tubes | Class II | Terminated |
| D-0884-2023 | 06-05-2023 | DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15 | cGMP deviations | Homeocare Laboratories, Inc. / 12,850 tottles | Class II | Terminated |
| D-0882-2023 | 06-05-2023 | Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01 | cGMP deviations | Homeocare Laboratories, Inc. / 5,956 bottles | Class II | Terminated |
| D-0883-2023 | 06-05-2023 | Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01 | cGMP deviations | Homeocare Laboratories, Inc. / 5957 bottles | Class II | Terminated |
| D-0881-2023 | 06-05-2023 | Arnica 7 Cream, net wt 2 oz (56.7g), Manufactured for: Brazmedics, LLC, New York, NY 10021 UPC 8 60208 00181 6 | cGMP deviations | Homeocare Laboratories, Inc. / 2,376 bottles | Class II | Terminated |
| D-0893-2023 | 05-31-2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08 Package NDCs: 0904-6269-08; 0904-6269-45; 0904-6270-08; 0904-6270-45; 0904-6271-08; 0904-6271-45; 0904-6272-08; 0904-6272-45 | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg. | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories / unknown | Class I | Terminated |
| D-0876-2023 | 05-30-2023 | Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10. Package NDCs: 65162-212-03; 65162-212-10; 65162-212-50; 65162-212-11 | Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification) | Amneal Pharmaceuticals of New York, LLC / 9,056 bottles | Class II | Terminated |
| D-0891-2023 | 05-30-2023 | Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by Sun Pharmaceutical Medicare Limited, Baska Ujeti Road, Ujeti, Halol-389350, Gujarat, India, NDC 62756-0233-01 | Subpotent drug | SUN PHARMACEUTICAL INDUSTRIES INC / 12960 vials | Class II | Terminated |
| D-0867-2023 | 05-25-2023 | Travoprost Ophthalmic Solution, USP (Ionic Buffered Solution), 0.004%, Rx only, Manufactured by Apotex Inc., Manufactured by: GSMS Incorporated, Camarillo, CA 93012, a) NDC 51407-731-25 (2.5 mL bottle), b) NDC 51407-731-05 (5 mL bottle). Package NDCs: 51407-731-25; 51407-731-05 | Lack of Assurance of Sterility: Tamper Evidence Seal is missing on secondary container. | Golden State Medical Supply Inc. / 1,920 bottles | Class II | Terminated |
| D-0866-2023 | 05-25-2023 | Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05 | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess. | Viatris Inc / 2,736 boxes | Class II | Terminated |
| D-0777-2023 | 05-23-2023 | Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10 Package NDCs: 49230-300-10 | Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. | Fresenius Medical Care Holdings, Inc. / 53,424 bags | Class II | Terminated |
| D-0765-2023 | 05-22-2023 | Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35. Package NDCs: 0363-9947-29; 0363-9947-35; 0363-9947-40 | Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity. | Aurobindo Pharma USA Inc. / 87,360 bottles | Class II | Completed |
| D-0778-2023 | 05-22-2023 | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25 | Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride | New England Life Care, Inc. dba Advanced Compounding Solutions / 198 | Class III | Terminated |
| D-0762-2023 | 05-19-2023 | Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 2,249,980 vials | Class II | Ongoing |
| D-0764-2023 | 05-19-2023 | Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 370,200 bottles | Class II | Ongoing |
| D-0763-2023 | 05-19-2023 | Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10 | Lack of Assurance of Sterility | Sagent Pharmaceuticals Inc / 2,249,980 vials | Class II | Ongoing |
| D-0877-2023 | 05-18-2023 | Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Package NDCs: 13107-014-01; 13107-015-01 | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / | Class III | Terminated |
| D-0760-2023 | 05-16-2023 | FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238, | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Alpha Aromatics / 544 1 gallon bottles | Class II | Terminated |
| D-0617-2023 | 05-15-2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-095-02 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 66,175 vials | Class II | Terminated |
| D-0593-2023 | 05-15-2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30 | Lack of Assurance of Sterility | Astral SteriTech Private Ltd. / 1,229,090 vials | Class II | Terminated |
