Drug Recalls

Drug Depot, Inc., dba APS Pharmacy

Class II Terminated

TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable, Packaged in a multi dose 10ML vial, as a) 5 ML Formula ID 115678; b) 10 ML Formula ID 115498, APS Pharmacy

Reason: Lack of sterility assurance.

D-0732-2022 April 6, 2022 Palm Harbor, FL

Drug Depot, Inc., dba APS Pharmacy

Class II Terminated

TESTOSTERONE CYPIONATE *GS* (2 mL) 80 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 127492, APS Pharmacy

Reason: Lack of sterility assurance.

D-0735-2022 April 6, 2022 Palm Harbor, FL

Drug Depot, Inc., dba APS Pharmacy

Class II Terminated

TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil (10 ML) 160MG/20MG/ML Injectable, Packaged in a multi dose 10ml vial, Formula ID 115498, APS Pharmacy

Reason: Lack of sterility assurance.

D-0733-2022 April 6, 2022 Palm Harbor, FL

Drug Depot, Inc., dba APS Pharmacy

Class II Terminated

TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable, Packaged in a multi dose 10ML vial, Formula ID 76681, APS Pharmacy

Reason: Lack of sterility assurance.

D-0734-2022 April 6, 2022 Palm Harbor, FL

Akorn, Inc.

Class II Terminated

TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30

Reason: Lack of Assurance of Sterility

D-0717-2022 March 30, 2022 Lake Forest, IL

Family Pharmacy of Statesville

Class II Terminated

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0657-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0662-2022 March 23, 2022 Statesville, NC

B. Braun Medical, Inc.

Class II Terminated

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

Reason: Lack of sterility assurance: leaking bags

D-0655-2022 March 23, 2022 Allentown, PA

Family Pharmacy of Statesville

Class II Terminated

Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0667-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0664-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0663-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0658-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0659-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0665-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0661-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0666-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0660-2022 March 23, 2022 Statesville, NC

Family Pharmacy of Statesville

Class II Terminated

Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Reason: Lack of Assurance of Sterility

D-0656-2022 March 23, 2022 Statesville, NC

Revive Rx LLC dba Revive Rx Pharmacy

Class I Terminated

HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.

Reason: Non-sterility; bacterial contamination identified as Paenibacillus lautus.

D-0648-2022 February 23, 2022 Houston, TX

CooperSurgical, Inc

Class I Terminated

PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health In...

Reason: Non-sterility

D-0643-2022 February 23, 2022 North Tonawanda, NY

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy

Class II Ongoing

Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083

Reason: Lack of Assurance of Sterility

D-0463-2022 February 9, 2022 Union, NJ

Edge Pharma, LLC

Class II Terminated

Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05

Reason: Lack of Assurance of Sterility

D-0406-2022 February 2, 2022 Colchester, VT

Edge Pharma, LLC

Class II Terminated

Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colches...

Reason: Lack of Assurance of Sterility

D-0397-2022 February 2, 2022 Colchester, VT

Edge Pharma, LLC

Class II Terminated

Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 0544...

Reason: Lack of Assurance of Sterility

D-0395-2022 February 2, 2022 Colchester, VT

Edge Pharma, LLC

Class II Terminated

Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pha...

Reason: Lack of Assurance of Sterility

D-0424-2022 February 2, 2022 Colchester, VT

FDA Enforcement Report