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Showing 6161–6180 of 15081 results

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Quick-Care Foam Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Oxytocin NS 500 mL (Advanced Pharma) – Superpotent Drug (2019)

Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.

FDAFeb 6, 2019Nationwide• Advanced Pharma Inc.

Moisturizing Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Gel Hand Sanitizer (Ecolab) – Benzene Contamination (2019)

Chemical Contamination: low levels of various substituted benzene (aromatic) compounds identified in the product after complaints of malodor.

Class IIModerate

FDAFeb 6, 2019Nationwide• Ecolab Inc

Moisturizing Lubricant Eye Drops (Akorn) – Stability Failure (2019)

Failed Stability Specification: out of specification results for Sodium Perborate

Class IIModerate

FDAFeb 4, 2019Nationwide• Akorn Inc

Sodium Chloride Injection (ICU Medical) – CGMP Deviation (2019)

CGMP Deviations

Class IIModerate

FDAFeb 4, 2019Nationwide• ICU Medical Inc

Dymista Nasal Spray (Mylan) – Broken Glass Risk (2019)

Defective Container: Potential for broken glass in the neck area of the glass bottles.

Class IIModerate

FDAFeb 1, 2019Nationwide• Mylan Pharmaceuticals Inc.

Moxifloxacin Eye Drops (Lupin) – Impurity Concerns (2019)

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

FDAFeb 1, 2019Nationwide• Lupin Pharmaceuticals Inc.

Levoleucovorin Injection (Mylan) – Particulate Contamination (2019)

Presence of Particulate Matter: particulate matter identified as copper salts

FDAFeb 1, 2019Nationwide• Mylan Institutional Inc

Divalproex Sodium Tablets (Dr. Reddy's) – Dissolution Failure (2019)

Failed Dissolution Specifications: Out of specification results observed for high dissolution.

Class IIModerate

FDAJan 31, 2019Nationwide• Dr. Reddy's Laboratories, Inc.

Cardizem CD 120mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Diltiazem HCl CD 360mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 300mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 180mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Cardizem CD 240mg (Valeant) – Dissolution Failure (2019)

Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.

FDAJan 30, 2019Nationwide• Valeant Pharmaceuticals North America LLC

Ephedrine Sulfate Syringe (US Compounding) – sterility concern (2019)

Lack of assurance of sterility.

Class IIModerate

FDAJan 29, 2019Nationwide• US Compounding Inc

Bimatoprost Ophthalmic Solution (Lupin) – impurity specification (2019)

Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.

FDAJan 28, 2019Nationwide• Lupin Pharmaceuticals Inc.

Silver Bullet 10x Capsules (Natures Rx) – undeclared ingredients (2019)

Undeclared Allergen

Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil

FDAJan 25, 2019Nationwide• Natures Rx

Clobetasol Propionate Cream (Akorn) – stability failure (2019)

Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.

FDAJan 25, 2019Nationwide• Akorn Inc

BromSite Ophthalmic Solution (Sun Pharmaceutical) – sterility risk (2019)

Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.

Class IIModerate

FDAJan 24, 2019Nationwide• Sun Pharmaceutical Industries, Inc.

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