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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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Drug Recall Terminated Historical recordClass II

Obagi Nu-Derm Clear, AM PM 3, Skin Bleaching and Corrector Cream, Hydroquinone USP, 4%, Rx Only, Net Wt. 2 OZ. (57 g) bottle, Dist by OMP Inc, Long Beach CA 90802, Made in USA, NDC 62032-101-36

by Obagi Medical Products

Reason: Labeling: Label Mix-Up; Containers of the Obagi Nu-Derm Clear pre-labeled bottles were inadvertently introduced into the Obagi Exfoderm Forte packaging line. Therefore customers which ordered Clear RX actually had contents of Exfoderm forte.
Recall initiated: October 17, 2014
Reported by FDA: November 12, 2014
Distribution: Nationwide and Mexico and Slovenia

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Drug Recall Terminated Historical recordClass II

VITAMIN B COMPLEX (PRES) injectable, 100mg, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070.

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

VANCOMYCIN, 1mg/0.1mL, injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

TRIESENCE, 8mg/2.0mL, Injectable, 0.2 mL plastic syringe, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

TOBRAMYCIN, 480mg/1000 mL, solution for irrigation, 500 mL plastic bottle, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE (SESAME OIL/CMPD), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE (GRAPE SEED OIL/COMPOUNDED), 200mg/mL, injectable, 5 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PYRIDOXINE HCL, with preservative, 100 mg/mL, injectable, 30 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PROCAINE HCL (BUFF), 1%, injectable, 10 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PREDNISOLONE Sodium Phosphate, 1%, Ophthalmic, 1 mL plastic dropper bottle, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.44mg/0.64mg/5.8mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection..
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE/PHENTOLAMINE/ALPROSTADIL, 26.5mg/0.98mg/58.9mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE HCL/PHENTOLAMINE/PROSTAGLANDIN, 27.7mg/0.45mg/45.45mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE HCL/PHENTOLAMINE MES/PROSTAGLANDIN, 23mg/0. 96mg/19.23mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

PAPAVERINE HCL, with preservative, 30 mg/mL, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

OMNIPAQUE, 300mgI/mL, injectable, 2 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

MITOMYCIN, 0.3mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Drug Recall Terminated Historical recordClass II

MITOMYCIN, 0.2mg/mL, injectable, 1 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070

by Oregon Compounding Centers, Inc. dba Creative Compounds

Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Recall initiated: October 6, 2014
Reported by FDA: November 12, 2014
Distribution: Oregon, Washington

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Data last updated: September 29, 2026 ET

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.