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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 16,701–16,720 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

PGE-1, 100 mcg/mL Injection in Normal Saline, 50 mL, University Compounding Pharmacy, 855-398-1800.

by University Compounding Pharmacy

Reason
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recall initiated
September 6, 2013
Reported by FDA
September 18, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.

by University Compounding Pharmacy

Reason
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recall initiated
September 6, 2013
Reported by FDA
September 18, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate/Testosterone Propionate 180-20 mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

by University Compounding Pharmacy

Reason
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recall initiated
September 6, 2013
Reported by FDA
September 18, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone CYP (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

by University Compounding Pharmacy

Reason
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recall initiated
September 6, 2013
Reported by FDA
September 18, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate (Sesame Oil) 200mg/mL Injection, 10 mL Vial, University Compounding Pharmacy, 855-398-1800.

by University Compounding Pharmacy

Reason
Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Recall initiated
September 6, 2013
Reported by FDA
September 18, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

by Creative Compounds

Reason
Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.
Recall initiated
August 23, 2013
Reported by FDA
September 18, 2013
Distribution
Oregon and Washington

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Drug Recall Terminated Historical recordClass II

MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

B-12 REJUV 25 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ASCORBIC ACID (CORN SOURCE) 500 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

VITAMIN B-COMPLEX INJECTABLE, VITAMIN B-COMPLEX SL SOLN and VITAMIN B-COMPLEX (PF) INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIPLE-TESTOSTERONE 250 MG/ML OIL INJ SOLN and TRIPLE-TESTOSTERONE 200 MG/ML OIL INJ SOLN, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

View recall →

Drug Recall Terminated Historical recordClass II

TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

by Beacon Hill Medical Pharmacy, P.C.

Reason
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
Recall initiated
July 26, 2013
Reported by FDA
September 18, 2013
Distribution
USA nationwide

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.