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Showing 1001–1020 of 1639 results

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Alprazolam C-IV 2mg (Direct Rx) – Cross Contamination Risk (2023)

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIModerate

FDAMar 22, 2023Nationwide• Direct Rx

Alprazolam C-IV 1mg (Direct Rx) – Cross Contamination Risk (2023)

CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.

Class IIModerate

FDAMar 22, 2023Nationwide• Direct Rx

Aripiprazole Tablets (Ascend Laboratories) – Spectroscopic Test Failure (2023)

Out of specification (OOS) for Spectroscopic Identification test by IR.

Class IIModerate

FDAMar 17, 2023Nationwide• Ascend Laboratories, LLC

Doxazosin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

BusPIRone Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Nurtec ODT (Pfizer) – Packaging Safety Issue (2023)

This recall involves prescription drugs Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of 8 tablets. The tablets are in a non-child resistant blister card packaged in a carton that includes the name of the product, dosage strength, expiration date. The dosage strength and expiration date are printed or stamped on the blister card. The recall includes the following: Product Description NDC Number Expiration Date Nurtec® ODT (rimegepant) 75mg 8-Unit Dose blister pack 72618-3000-2 All dates through 6/2026

CPSCMar 16, 2023Nationwide• Biohaven Pharmaceuticals Inc., of New Haven, Conn.

Tadalafil Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Atorvastatin Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Epinephrine Kit (Focus Health Group) – Incorrect Labeling (2023)

Labeling; Incorrect NDC number on outer carton of product.

FDAMar 16, 2023Nationwide• Focus Health Group Inc

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Glimepiride Tablets (Northwind Pharmaceuticals) – Manufacturing Deviation (2023)

CGMP Deviations

Class IIModerate

FDAMar 16, 2023Nationwide• Northwind Pharmaceuticals LLC

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

Pantoprazole Tablets (Hetero USA) – Discoloration Issue (2023)

CGMP Deviations: Discoloration

Class IIModerate

FDAMar 14, 2023Nationwide• Hetero USA Inc

Atovaquone Oral Suspension 750mg (Camber) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

FDAMar 13, 2023Nationwide• Camber Pharmaceuticals Inc.

Daytrana 10mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 15mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 20mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

Daytrana 30mg Patch (Noven) – Delivery System Defect (2023)

Defective Delivery System: Out of specification for shear.

Class IIModerate

FDAMar 10, 2023Nationwide• Noven Pharmaceuticals Inc

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