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Showing 761–780 of 1639 results

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Libigrow Red Dragon+ (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Infumorph (Hikma) – expired filter (2024)

The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Class IIModerate

FDAMar 12, 2024Nationwide

• Hikma Pharmaceuticals USA Inc.

Febuxostat 80mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Treprostinil Injection (Par) – particulate matter (2024)

Presence of Particulate Matter.

FDAMar 4, 2024Nationwide• Par Sterile Products LLC

Febuxostat 40mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Phenylephrine HCl (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

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

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

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

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

Failed Dissolution Specifications

Class IIModerate

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

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

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

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

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

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

CGMP Deviations: potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 9, 2024Nationwide• Apotex Corp.

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