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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 2081–2100 of 17,711 recalls

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 IIOngoing

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

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Lack of Assurance of Sterility

July 13, 2023 · DrugView details →

Class IIOngoing

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.

Ascend Laboratories, LLC

Failed Dissolution Specifications

July 11, 2023 · DrugView details →

Class IIOngoing

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.

Sagent Pharmaceuticals

Lack of Assurance of Sterility

July 11, 2023 · DrugView details →

Class IIOngoing

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.

Sagent Pharmaceuticals

Lack of Assurance of Sterility

July 11, 2023 · DrugView details →

Class IIOngoing

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.

Sagent Pharmaceuticals

Lack of Assurance of Sterility

July 11, 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 IIOngoing

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.

Tenn South Distillery LLC dba Big Machine Distillery

CGMP Deviation: impurities exceed allowable limits.

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 →

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