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Showing 8521–8540 of 15081 results

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Dextroamphetamine Tablets (Amerisource) – Mispackaging Risk (2016)

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Class IIModerate

FDAAug 24, 2016Nationwide• Amerisource Health Services

Dextroamphetamine Tablets (Amerisource) – Mispackaging Risk (2016)

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Class IIModerate

FDAAug 24, 2016Nationwide• Amerisource Health Services

Dextroamphetamine Saccharate (Amerisource) – Mispackaging Risk (2016)

Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule

Class IIModerate

FDAAug 24, 2016Nationwide• Amerisource Health Services

Selegiline HCL Tablets (Stason) – Dissolution Failure (2016)

Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.

FDAAug 23, 2016NC• Stason Pharmaceuticals, Inc.

Daytrana Patch (Noven) – Delivery System Defect (2016)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Class IIModerate

FDAAug 22, 2016Nationwide• Noven Pharmaceuticals, Inc.

Daytrana Patch (Noven) – Delivery System Defect (2016)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Class IIModerate

FDAAug 22, 2016Nationwide• Noven Pharmaceuticals, Inc.

Daytrana Patch (Noven) – Defective Delivery System (2016)

Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.

Class IIModerate

FDAAug 22, 2016Nationwide• Noven Pharmaceuticals, Inc.

Lamotrigine ODT (Impax) – Label Mixup (2016)

Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs

FDAAug 19, 2016Nationwide• Impax Laboratories, Inc.

Lamotrigine Tablets (Unichem) – Incorrect Tablet Imprint (2016)

Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.

FDAAug 19, 2016Nationwide• Unichem Pharmaceuticals Usa Inc

Amoxicillin Suspension (West-Ward) – Missing Label Panel (2016)

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

FDAAug 18, 2016Nationwide• West-Ward Pharmaceuticals Corp.

SYNEDREX (IQ Formulations) – Undeclared Ingredients (2016)

Products contain Picamilon and/or methylpentane citrate (DMBA), which are not recognized as a dietary ingredients

Class IIModerate

FDAAug 16, 2016Nationwide• IQ Formulations, LLC

Dobutamine Injection (Hospira) – Product Discoloration (2016)

Discoloration: Firm received complaints of product discoloration and particulates.

Class IIModerate

FDAAug 15, 2016Nationwide• Hospira Inc.

Cannibal Riot Pre-Workout (Chaos and Pain) – Undeclared Stimulants (2016)

The products are being recalled because they contain 750 mg of Agmatine and 50 mg 1,3 Dimethylbutylamine per serving which is not declared on the label. 1,3 Dimethylbutylamine is not permitted for use in dietary supplements in the EU.

Class IIModerate

FDAAug 10, 2016Nationwide• Chaos and Pain

Cannibal Riot Pre-Workout (Chaos and Pain) – Undeclared Stimulants (2016)

The products are being recalled because they contain 750 mg of Agmatine and 50 mg 1,3 Dimethylbutylamine per serving which is not declared on the label. 1,3 Dimethylbutylamine is not permitted for use in dietary supplements in the EU.

Class IIModerate

FDAAug 10, 2016Nationwide• Chaos and Pain

Ephedrine Sulfate Injection (Allergy) – Sterility Concerns (2016)

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

Class IIModerate

FDAAug 10, 2016Nationwide• Allergy Laboratories, Inc.

D-Vita Drops (Pharmatech) – Bacterial Contamination (2016)

Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.

Class IIModerate

FDAAug 8, 2016FL, MI, MS +1 more• Pharmatech LLC

Calcionate Syrup (Pharmatech) – Bacterial Contamination (2016)

Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.

Class IIModerate

FDAAug 8, 2016FL, MI, MS +1 more• Pharmatech LLC

Virtrate-K (Pharmatech) – Bacterial Contamination (2016)

Recall initiated as a precautionary measure due to potential risk of product contamination with Burkholderia cepacia.

Class IIModerate

FDAAug 8, 2016FL, MI, MS +1 more• Pharmatech LLC

Ninjacof-A Liquid (Pharmatech) – Bacteria Risk (2016)

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAAug 8, 2016Nationwide• Pharmatech LLC

Sennazon (Pharmatech) – Bacteria Contamination (2016)

CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.

Class IIModerate

FDAAug 8, 2016Nationwide• Pharmatech LLC

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