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Showing 7981–8000 of 15081 results

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Potassium PHOSphate (Pharmedium) – incorrect label volume (2017)

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

FDAFeb 17, 2017Nationwide• Pharmedium Services, LLC

Potassium CHLORide Sodium Chloride (Pharmedium Services) – Incorrect Label Volume (2017)

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

FDAFeb 17, 2017Nationwide• Pharmedium Services, LLC

Potassium PHOSphate Sodium Chloride (Pharmedium Services) – Incorrect Label Volume (2017)

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Class IIILow

FDAFeb 17, 2017Nationwide• Pharmedium Services, LLC

Vancomycin HCl Injection (Pharmedium Services) – Incorrect Label Volume (2017)

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Class IIModerate

FDAFeb 17, 2017Nationwide• Pharmedium Services, LLC

Vancomycin HCl Sodium Chloride Injection (Pharmedium Services) – Incorrect Label Volume (2017)

Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label.

Class IIModerate

FDAFeb 17, 2017Nationwide• Pharmedium Services, LLC

XtraHRD Enhancement Capsules (Organic Herbal Supply) – Unapproved Ingredient (2017)

Marketed without an Approved NDA/ANDA: Product contains N-desmethyl tadalafil an analogue to tadalafil which is an active pharmaceutical ingredient in a FDA approved drug used to treat erectile dysfunction (ED).

FDAFeb 16, 2017Nationwide• Organic Herbal Supply

HealthA2Z Chewable Aspirin (Allegiant Health) – Rubber Particle Contamination (2017)

cGMP deviations - presence of rubber particles found loose in the bulk product.

Class IIModerate

FDAFeb 16, 2017Nationwide• Allegiant Health

Optic Splash Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Sato Clear Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Dorama-Neo Eye Wash (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Zenatane Isotretinoin 30mg (Dr. Reddy's) – Dissolution Failure (2017)

Failed dissolution specifications - low dissolution results at S3 stage.

FDAFeb 15, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Ropivacaine HCl (Pharmedium Services) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Zenatane Capsules 10mg (Dr. Reddy's) – Dissolution Specification Failure (2017)

Failed dissolution specifications - low dissolution results at S3 stage.

FDAFeb 15, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Famciclovir Tablets (AVKARE) – Impurity Specifications (2017)

Failed impurities/ degradation specifications: Product was above specification for unknown impurities.

Class IIModerate

FDAFeb 15, 2017Nationwide• AVKARE Inc.

Zenatane Capsules 20mg (Dr. Reddy's) – Dissolution Specification Failure (2017)

Failed dissolution specifications - low dissolution results at S3 stage.

FDAFeb 15, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Ropivacaine HCl (Pharmedium Services) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Ropivacaine HCl ON-Q Pump 500mL (Pharmedium Services) – Missing Lot Date (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Zenatane Isotretinoin 40mg (Dr. Reddy's) – Dissolution Failure (2017)

Failed dissolution specifications - low dissolution results at S3 stage.

FDAFeb 15, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Bupivacaine HCl (Pharmedium Services) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

Ropivacaine HCl (Pharmedium Services) – Incorrect Labeling (2017)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAFeb 15, 2017Nationwide• Pharmedium Services Llc

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