Drug Recalls

Assurance Infusion

Class II Terminated

BUP 5MG/ HYDROM 15MG/ SUF 600MCG/ML (40ML) INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0712-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BAC 50MCG/ HYDROM 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0674-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

IPAMORELIN 2000MCG/ML INJ in 2 mL vial Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0748-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 10MG/HYDROM 15MG/SUF 200MCG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0682-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

MORPHINE 15MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0752-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

MORPHINE 10MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0751-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 8MG/CLON 100MCG/HYDROM 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0718-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 30MG/ MORP 8MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0701-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

BUP 675MCG/MORP 20MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0716-2020 January 22, 2020 Houston, TX

Assurance Infusion

Class II Terminated

HYDROMORPHONE 2MG/ML INJ in 20 mL syringe Assurance Infusion (713) 533-8800

Reason: Lack of sterility assurance.

D-0743-2020 January 22, 2020 Houston, TX

Surgery Pharmacy Services Inc

Class II Terminated

Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Serv., 3908 TENN.AVE., SUITE F., CHATTANOOGA, TN., 37409,

Reason: Lack of sterility assurance.

D-0610-2020 December 18, 2019 Chattanooga, TN

Surgery Pharmacy Services Inc

Class II Terminated

Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Specific volumes. Mixed by Surgery Pharmacy Services,3908 TENN.AVE. CHATT,TN37409

Reason: Lack of sterility assurance.

D-0611-2020 December 18, 2019 Chattanooga, TN

New Vitalis Pharmacy LLC dba New Vitalis Pharmacy

Class II Terminated

Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy

Reason: Lack of sterility assurance.

D-0523-2020 December 4, 2019 Louisville, KY

Altaire Pharmaceuticals, Inc.

Class II Completed

CVS Health Lubricant Eye Drops Lasting Dry Eye Relief, Twin Pack, Item#: 495323, Product Size: 2 x 10 mL, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

Reason: Lack of Assurance of Sterility

D-0409-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Equate Comfort Gel Lubricant Eye Gel Twin Pack W-M item #: 552374319, Package Size: 2 x 15 mL, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-197-49

Reason: Lack of Assurance of Sterility

D-0366-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution, USP (Sterile) 5 mL Rx only, Manufactured for OCuSOFT, Inc. Richmond, TX 77406-0429, NDC 54799-507-21

Reason: Lack of Assurance of Sterility

D-0449-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Natural Ophthalmics Ortho-K Thick Comfort Gel, 15 mL, NDC 68770-143-15

Reason: Lack of Assurance of Sterility

D-0462-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic Single Dose 0.6 mL, Rx only, Mfd. for OCuSOFT, Inc. PO Box 429 Richmond, TX 77406-0429 800-233-5469 Made in USA, Mfd. by: Altaire Pharmaceutica...

Reason: Lack of Assurance of Sterility

D-0445-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 0.5 Fl. Oz. (15 mL), Item #317914, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895

Reason: Lack of Assurance of Sterility

D-0376-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Natural Ophthalmics Ortho-K Thin Eye Drops, 15 mL, NDC 68770-144-15

Reason: Lack of Assurance of Sterility

D-0464-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

CVS Health Preservative Free Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5% Glycerin 0.9%) Sensitive Solution, 30 Sterile Single-Use Containers, 0.02 fl. oz. (0.6 mL) each, Item #994883, Dist...

Reason: Lack of Assurance of Sterility

D-0379-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50

Reason: Lack of Assurance of Sterility

D-0365-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic Ointment, Net. Wt 3.5 gm, Sterile, Rx only, Manufactured for Perrigo Minneapolis, MN 55427, NDC 0574-4160-35

Reason: Lack of Assurance of Sterility

D-0352-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

Grandall Colirio Ojo De Aguila Eye Drops, Sterile, Net Wt 1/2 fl oz (15 mL) Dist. By Grandall Distributing Co.Inc., Glendale, CA 91204-2707

Reason: Lack of Assurance of Sterility

D-0459-2020 November 27, 2019 Aquebogue, NY

Altaire Pharmaceuticals, Inc.

Class II Completed

CVS Health Dry Eye Relief Lubricant Eye Drops, Sterile, 1 Fl. Oz. (30 mL), Item #457802, Distributed by: CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02895

Reason: Lack of Assurance of Sterility

D-0377-2020 November 27, 2019 Aquebogue, NY

FDA Enforcement Report