Drug Recalls

17,680 Records

Prescription & OTC drug enforcement reports

2,152 results found for contamination Page 6 of 87

Church & Dwight Inc

Class I Ongoing

TheraBreath for Kids! Oral Rinse, sodium fluoride 0.05% (0.02% w/v fluoride ion), 16 fl. oz. 473 mL bottles, Strawberry Splash, UPC 6 97029 70000 6, manufactured for Church & Dwight Co, Inc., Ewing, N...

Reason: Microbial contamination of Non-Sterile Product; presence of yeast identified as Candida parapsilosis

D-0046-2024 October 25, 2023 Princeton, NJ

VistaPharm LLC

Class I Terminated

Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottles per case), Rx Only, Manufactured and Distributed by: VistaPharm, Inc. Largo, FL 33771 USA, NDC 66689-305-16

Reason: Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus.

D-0047-2024 October 25, 2023 Largo, FL

Scynexis, Inc.

Class I Completed

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04

Reason: Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

D-0042-2024 October 18, 2023 Jersey City, NJ

Lundbeck LLC

Class III Completed

Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC 67386-211-65

Reason: Cross contamination with other products

D-1142-2023 September 6, 2023 Deerfield, IL

Central Admixture Pharmacy Services, Inc.

Class II Terminated

heparin 4000 units/1000mL added to 0.9% sodium chloride, 4 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-7022-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0978-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 2%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0985-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

rocuronium50 mg/5 mL (10 mg/mL), Syringes Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0947-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0951-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

vancomycin 750 mg/250 mL added to 0.9% Sodium Chloride, (3 mg/mL), IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6071-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0971-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

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 4...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1029-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2%/Dextrose 5% with CALCIUM and HEPARIN, total volume = 250mL, IV Bag, Rx Only, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd A...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0994-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 30 mEq K, Induction 4:1, High Potassium, IV Bag, total volume = 415 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1017-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 15 mEq K, Reperfusate 4:1, low potassium, IV Bag, total volume = 477.5mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1022-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

heparin 2500 units/500mL added to 0.9% sodium chloride 5 units/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0977-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0953-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

PHENYLephrine 20mg/250ml added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0961-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

vancomycin 1.5 g/250mL added to 5% dextrose, 6 mg/mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6075-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0968-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0954-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 108 mEq K, Induction 8:1, High Potassium, IV Bag, total volume = 500 mL, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0102-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1032-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

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: ...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1006-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

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

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0989-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8097-1

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0987-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 3%/Dextrose 10%, total volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 7...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-0997-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1 non-enriched, Low Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 850...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1041-2023 August 9, 2023 Phoenix, AZ

Central Admixture Pharmacy Services, Inc.

Class II Terminated

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, ...

Reason: Lack of assurance of sterility. Validation data for decontamination cycles is lacking.

D-1011-2023 August 9, 2023 Phoenix, AZ