Drug Recalls

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0063-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0037-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0043-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0061-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0029-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0032-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0035-2022 November 3, 2021 Mesa, AZ

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

Class II Terminated

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

Reason: Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns

D-0042-2022 November 3, 2021 Mesa, AZ

SSM Health Care St. Louis DBA SSM St. Clare Health Center

Class II Terminated

Potassium Chloride 40 mEq in 0.9% Sodium Chloride 270 mL NS, 250 mL bag, Rx Only, SSM Health Care Corporation, 1015 Bowles, Fenton, MO. NDC 60652-6429-1

Reason: Lack of Assurance of Sterility

D-0007-2022 October 20, 2021 Fenton, MO

Akorn, Inc.

Class II Terminated

Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 1...

Reason: Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.

D-0004-2022 October 13, 2021 Lake Forest, IL

AMIVAS (US), LLC

Class II Terminated

Artesunate for Injection, 110 mg/vial, packaged in a) 2x2 pack containing 2 Single-dose vials artesunate (73607-001-01) and 2 vials sterile diluent (NDC 73607-001-02) per carton (NDC 73607-001-11); 4x...

Reason: Lack of Assurance of Sterility: Air filter failed post integrity test leading to a lack of sterility assurance.

D-0002-2022 October 13, 2021 Frederick, MD

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Class II Terminated

Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213

Reason: Lack of Assurance of Sterility

D-0899-2021 October 6, 2021 Louisville, KY

IntegraDose Compounding Services LLC

Class II Terminated

ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1

Reason: Lack of sterility assurance.

D-0896-2021 October 6, 2021 Minneapolis, MN

Fresenius Kabi USA LLC

Class II Terminated

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Reason: Defective container: Cracked vials leading to lack of sterility assurance

D-0856-2021 October 6, 2021 Melrose Park, IL

IntegraDose Compounding Services LLC

Class II Terminated

ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1

Reason: Lack of sterility assurance.

D-0897-2021 October 6, 2021 Minneapolis, MN

Glenmark Pharmaceuticals Inc., USA

Class II Terminated

Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32

Reason: Lack of Assurance of Sterility

D-0820-2021 September 29, 2021 Mahwah, NJ

Glenmark Pharmaceuticals Inc., USA

Class II Terminated

Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals ...

Reason: Lack of Assurance of Sterility

D-0827-2021 September 29, 2021 Mahwah, NJ

Prescription Labs Inc dba Greenpark

Class II Terminated

Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy

Reason: Lack of Assurance of Sterility

D-0804-2021 September 22, 2021 Houston, TX

Akorn, Inc.

Class II Terminated

Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-062-35

Reason: Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member ...

D-0786-2021 September 8, 2021 Lake Forest, IL

ANHUI WELCOME FOREIGN TRADE CO.,LTD.

Class II Terminated

Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (0.34 fl/oz) Exclusive U.S. Distributor: (Chinese writing)International Nature Nutraceuticals, Inc. New York, NY 10002 www.I...

Reason: Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, they are manufactured as nasal drops and sterility cannot be assured.

D-0755-2021 September 1, 2021 Hefei, N/A

SterRx, LLC

Class I Terminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903 NDC 70324-326-01

Reason: Non-Sterility: firm's third party lab confirmed microbial contamination.

D-0767-2021 September 1, 2021 Plattsburgh, NY

SterRx, LLC

Class II Terminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903

Reason: Lack of Assurance of Sterility

D-0768-2021 September 1, 2021 Plattsburgh, NY

Custopharm, Inc.

Class II Terminated

FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, Rx Only, Mfd for: Leucadia Pharmaceuticals Carlsbad, CA 92011 U.S.A, NDC 24201-237-01

Reason: Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.

D-0765-2021 September 1, 2021 Carlsbad, CA

Teva Pharmaceuticals USA

Class II Terminated

Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01

Reason: Lack of Assurance of Sterility

D-0741-2021 August 25, 2021 Parsippany, NJ

Teva Pharmaceuticals USA

Class II Terminated

Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01

Reason: Lack of Assurance of Sterility

D-0745-2021 August 25, 2021 Parsippany, NJ

FDA Enforcement Report