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Showing 8121–8140 of 15081 results

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Hydrocodone Acetaminophen Solution (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Methadone Concentrate (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Oxycodone Solution (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Nystatin Suspension (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Phenytoin Suspension (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Methadone Concentrate (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Methadone Concentrate (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Potassium Chloride Solution (VistaPharm) – Leaking Container (2017)

Defective Container: Leakage of unit dose cups that may occur at the seal.

Class IIModerate

FDAJan 18, 2017AL, AZ, CA +33 more• VistaPharm, Inc.

Nystatin Suspension (VistaPharm) – Water Contamination (2017)

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIModerate

FDAJan 18, 2017Nationwide• VistaPharm, Inc.

Sinus & Lung Care (Penn Herb) – Ingredient Mix-Up (2017)

There was a mix-up with ingredients used. The product is an herbal blend consisting of 7 different herbs. The blend calls for Ginger Root; however, Ginkgo Leaves was accidentally added.

FDAJan 17, 2017Nationwide• Penn Herb Company, Ltd.

Taclonex Suspension (LEO Pharma) – Outdated Insert (2017)

Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.

FDAJan 16, 2017Nationwide• LEO PHARMA INC

Dexamethasone Elixir (Qualitest) – Impurity Specifications (2017)

Failed Impurities/ Degradation Specifications

FDAJan 16, 2017Nationwide• Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals

Duopa (AbbVie) – Failed Stability Test (2017)

Failed Stability Specifications: confirmed out of specification results obtained during refrigerated material stability testing indicating that drug may settle within drug cassettes nearing the end of their refrigerated shelf-life

Class IIModerate

FDAJan 13, 2017IL, TN• AbbVie Inc.

Carbidopa and Levodopa Tablets (Sun Pharma) – Failed Dissolution (2017)

Failed Dissolution Specifications

Class IIModerate

FDAJan 12, 2017Nationwide• Sun Pharmaceutical Industries, Inc.

Albuterol Sulfate Inhalation Solution (Actavis) – Impurities Degradation (2017)

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

FDAJan 12, 2017Nationwide• Actavis Inc

Xambo Capsules (West Coast Laboratories) – DMAA Presence (2017)

West Coast Laboratories is recalling Xambo and Devagrass because there may be presence of 1,3-dimethylamylamine (DMAA).

Class IIModerate

FDAJan 11, 2017Nationwide• West Coast Laboratories Inc

Docetaxel Injection (Dr. Reddy's) – Defective Container (2017)

Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.

Class IIModerate

FDAJan 9, 2017Nationwide• Dr. Reddy's Laboratories, Inc.

Montelukast Sodium Tablets (Hetero) – Discoloration Issue (2017)

Discoloration: the firm received a complaint of a sealed bottle in which tablets inside had blue spots and a blue powder inside the bottle.

FDAJan 7, 2017Nationwide• Hetero USA Inc

Fluconazole Tablets 200mg (Harvard) – Failed Dissolution (2017)

Failed Dissolution Specifications

Class IIModerate

FDAJan 5, 2017Nationwide• The Harvard Drug Group

Diphenhydramine HCl Softgel (InnovaGel) – Subpotent (2017)

Subpotent

FDAJan 5, 2017NY• InnovaGel

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