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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 541–560 of 1,000 recalls

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC:72196-6037-1

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · Drug

View details →

Class IITerminated

oxyTOCIN 10 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6036-1

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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: 72196-0106-1

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

CARDIOPLEGIA SOLUTION, 70 mEq K, Induction 8:1, non-enriched, High Potassium, IV Bag, Total Volume = 300 mL, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0214-1

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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

Central Admixture Pharmacy Services, Inc.

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

July 14, 2023 · DrugView details →

Class IITerminated

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.

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of Foreign Substance: Metal embedded in a tablet.

July 13, 2023 · DrugView details →

Class IITerminated

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;

New England Life Care, Inc. dba Advanced Compounding Solutions

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

July 10, 2023 · DrugView details →

Class IITerminated

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

New England Life Care, Inc. dba Advanced Compounding Solutions

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

July 10, 2023 · DrugView details →

Class IITerminated

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

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing

July 10, 2023 · DrugView details →

Class IITerminated

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

New England Life Care, Inc. dba Advanced Compounding Solutions

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

July 10, 2023 · DrugView details →

Class IITerminated

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;

New England Life Care, Inc. dba Advanced Compounding Solutions

CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.

July 10, 2023 · DrugView details →

Class IITerminated

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.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

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.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

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.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

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