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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 3,201–3,220 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

by Fresenius Kabi USA, LLC

Reason
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Recall initiated
November 22, 2022
Reported by FDA
January 25, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.

by Northern VA Compounders PLLC

Reason
Lack of Assurance of Sterility
Recall initiated
December 30, 2022
Reported by FDA
January 18, 2023
Distribution
Nationwide in the USA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.