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Showing 761–780 of 1571 results

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FentaNYL Citrate (SSM Health) – sterility validation (2024)

Lack of Assurance of Sterility: Firm did not perform process validation.

Class IIModerate

FDAFeb 29, 2024MO• SSM Health Care St. Louis DBA SSM St. Clare Health Center

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Lidocaine HCL Solution (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Moxifloxacin Single-Dose Vial (Denver Solutions) – glass delamination (2024)

Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.

Class IIModerate

FDAFeb 20, 2024Nationwide• Denver Solutions, LLC DBA Leiters Health

Nicardipine Hydrochloride Injection (Eugia) – impurity specs (2024)

Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Class IIModerate

FDAFeb 20, 2024Nationwide• Eugia US LLC

Methylprednisolone Acetate Injection (Eugia) – dissolution failure (2024)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 20, 2024LA, MS, OH +1 more• Eugia US LLC

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Broncochem Kids Cold & Flu Syrup (Global Corporation) – stability testing failures (2024)

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Class IIModerate

FDAFeb 16, 2024Nationwide• Global Corporation

Broncochem Cold & Tea (Global Corporation) – stability testing failures (2024)

Stability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.

Class IIModerate

FDAFeb 16, 2024Nationwide• Global Corporation

Methocarbamol Injection (Eugia) – particulate matter (2024)

Presence of Particulate Matter

FDAFeb 15, 2024Nationwide• Eugia US LLC

Fluticasone Nasal Spray (Golden State Medical) – bacterial contamination risk (2024)

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 14, 2024Nationwide• Golden State Medical Supply Inc.

Clobazam Tablets (Micro Labs) – Residual Solvent Issue (2024)

CGMP Deviations: Out of specification for residual solvents.

Class IIModerate

FDAFeb 12, 2024Nationwide• Micro Labs Limited

Fluticasone Nasal Spray (Apotex) – Bacterial Contamination Risk (2024)

CGMP Deviations: potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 9, 2024Nationwide• Apotex Corp.

Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: results slightly under spec at at 9-months.

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

Tejocote Root Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product is being recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Terlivaz Injection (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

Arize Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

Sustain Herbal Supplement (Today The World) – Undeclared Tadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

SCHWINNNG Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

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