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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 13661–13680 of 17,832 recalls

Class ITerminated

Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.

Mylan Institutional LLC

Presence of Particulate Matter

March 23, 2015 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31

Baxter Healthcare Corp

Lack of Assurance of Sterility; increased complaints received for leaks

March 23, 2015 · DrugView details →

Class ITerminated

Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.

Mylan Institutional LLC

Presence of Particulate Matter

March 23, 2015 · DrugView details →

Class ITerminated

Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.

Mylan Institutional LLC

Presence of Particulate Matter

March 23, 2015 · DrugView details →

Class IITerminated

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04

Baxter Healthcare Corp

Lack of Assurance of Sterility; increased complaints received for leaks

March 23, 2015 · DrugView details →

Class ITerminated

CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Multi-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-493-46, UPC 3 67457 49346 6.

Mylan Institutional LLC

Presence of Particulate Matter

March 18, 2015 · DrugView details →

Class IITerminated

5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04

Baxter Healthcare Corp.

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

March 18, 2015 · DrugView details →

Class ITerminated

Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, packaged in 5 x 2 mL vials per carton, Rx only, labeled as a) Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-0146-01; and b) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-467-99.

Mylan Institutional LLC

Presence of Particulate Matter

March 18, 2015 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03

Baxter Healthcare Corp.

Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.

March 18, 2015 · DrugView details →

Class IITerminated

Papaverine/phentolamine/prostaglandin 16/0.5/0.005 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Hydroxocobalamin 1) 1000mcg/mL, 2) 5mg/0.5mL, 3) 5000mcg/0.2mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Methylcobolamin 1) 6500 mcg/0.26mL, 2) 1000 mcg/0.08mL, 3) 5000mcg/mL, 4) 3000mcg/0.12mL, 5) 4000mcg/0.16mL, 6) 1000mcg/mL and 7) 1000 mcg/0.04mL injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Papaverine/phentolamine/prostaglandin 30/1/0.02 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn, Inc.

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

March 17, 2015 · DrugView details →

Class IITerminated

Papaverine/phentolamine/prostaglandin 30/1/0.01mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

Papaverine/phentolamine/prostaglandin 30/1/0.025 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110

Fallon Wellness Pharmacy, L.L.C.

Lack of assurance of sterility

March 17, 2015 · DrugView details →

Class IITerminated

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn, Inc.

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

March 17, 2015 · DrugView details →

Class IITerminated

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, CHERRY FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0823-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701

Akorn, Inc.

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

March 17, 2015 · DrugView details →

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