Mylan Institutional LLC

Rockford, IL, United States

15

Total Recalls

9

Class I Recalls

0

Ongoing Recalls

Recalls by Mylan Institutional LLC

FDA Drug Class III Terminated

Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 25 (2 mL multi-dose vial) per carton, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA; Manufactur

May 3, 2021 Mylan Institutional LLC 2,131 cartons units
FDA Drug Class I Terminated

Tranexamic Acid Injection, USP, 1000 mg/10 mL (100 mg/mL), 10 mL Single-Dose Vial (NDC 67457-197-00); 10 x 10 mL Single-Dose Vials per carton (NDC 67457-197-10), Rx only, Manufactured by: Mylan Instit

August 17, 2020 Mylan Institutional LLC 1407 cartons units
FDA Drug Class I Terminated

Amiodarone Hydrochloride Injection, USP, 450 mg/9 mL (50 mg/mL), 9 mL Single-Dose Vial (NDC 67457-153-99); 10 x 9 mL Single-Dose Vials per carton (NDC 67457-153-09), Rx only, Manufactured by: Mylan In

August 17, 2020 Mylan Institutional LLC 13,682 cartons units
FDA Drug Class I Terminated

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

July 7, 2020 Mylan Institutional LLC 18,480 vials units
FDA Drug Class II Terminated

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50

May 5, 2020 Mylan Institutional LLC 3,010 vials units
FDA Drug Class I Terminated

Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-0152-01), packaged in 10 x 5 mL Vials per carton (NDC 0069-0152-02), Rx only, Distributed by Pfizer Labs, Division of Pfize

April 23, 2015 Mylan Institutional LLC 8,340 vials units
FDA Drug Class I Terminated

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 67457-4

March 23, 2015 Mylan Institutional LLC a) 35,197 vials; b) 21,302 vials units
FDA Drug Class I Terminated

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 6745

March 23, 2015 Mylan Institutional LLC 2,455 vials units
FDA Drug Class I Terminated

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 6745

March 23, 2015 Mylan Institutional LLC 10,094 vials units
FDA Drug Class I Terminated

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, N

March 18, 2015 Mylan Institutional LLC a) 15,095 vials b) 300 vials units
FDA Drug Class I Terminated

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

March 18, 2015 Mylan Institutional LLC 4,445 vials units
FDA Drug Class II Terminated

Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Myl

February 18, 2015 Mylan Institutional LLC 2,523 cartons (25,936 vials) units
FDA Drug Class II Terminated

Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: M

February 18, 2015 Mylan Institutional LLC 11,030 cartons (55,150 vials) units
FDA Drug Class III Terminated

DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapi

February 11, 2015 Mylan Institutional LLC 936 vials units
FDA Drug Class III Terminated

Nicardipine Hydrochloride Injection, 25 mg/10 ml (2.5 mg/mL),10 mL single dose vial, Rx only, Manufactured in India for: Mylan Institutional LLC, Rockford, IL 61103, NDC 67457-224-10

January 23, 2015 Mylan Institutional LLC 78,090 vials units