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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 461–480 of 1,000 recalls

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 →

Class IITerminated

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.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

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.

SterRx, LLC

Lack of Assurance of Sterility

July 7, 2023 · DrugView details →

Class IITerminated

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

Teva Pharmaceuticals USA Inc

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

July 5, 2023 · DrugView details →

Class IITerminated

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

B. Braun Medical Inc.

Lack of assurance of sterility: bags have the potential to leak.

July 5, 2023 · DrugView details →

Class IITerminated

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.

Accord Healthcare, Inc.

Presence of Particulate Matter: Particulate matter identified as fiber.

July 3, 2023 · DrugView details →

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