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Showing 3921–3940 of 29086 results

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Allergy Relief Tablets (Perrigo) – Impurities Spec Failure (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Non-Drowsy Allergy Relief (Perrigo) - Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

ALLER-FEX Allergy Tablets (Perrigo) - Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Allergy Relief Tablets (Perrigo) – Impurities Spec Failure (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Fexofenadine Hydrochloride Tablets (Perrigo) - Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Allergy Relief Tablets (Perrigo) – Impurities Spec Failure (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Aller-Ease Allergy Tablets (Perrigo) - Impurity Specifications (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Allergy Relief Tablets (Perrigo) – Impurities Spec Failure (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 9, 2023Nationwide• L. Perrigo Company

Fentanyl and Ropivacaine Solution (Apollo Care) - Sterility Concern (2023)

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Class IIModerate

FDAFeb 8, 2023MO• Apollo Care

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Class IIModerate

FDAFeb 8, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

Cashew Crave Mix (Texas Star) – undeclared milk/soy (2023)

Undeclared Allergen

Undeclared milk and soy. The milk and soy allergens are listed in the "may contains" statement, but are not included in the "Contains" statement.

Class IIModerate

FDAFeb 7, 2023AL, CA, OH +2 more• Texas Star Nut and Food Co., Inc.

BusPIRone Hydrochloride Tablets 15 mg (Accord Healthcare) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

BusPIRone Hydrochloride 10mg (Accord Healthcare) – CGMP Issues (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Phenylephrine Injection (Accord) - Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Vigabatrin Oral Solution 500 mg (Accord Healthcare) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Daptomycin for Injection 500 mg (Accord Healthcare) – CGMP Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Pravastatin Sodium Tablets 80 mg (Accord Healthcare) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Glycopyrrolate Injection 0.2mg/mL (Accord Healthcare) – CGMP Issues (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Finasteride Tablets 5 mg (Accord Healthcare) – Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

Montelukast Sodium Tablets (Accord) - Manufacturing Deviation (2023)

CGMP Deviations: recalling drug products following an FDA inspection.

Class IIModerate

FDAFeb 7, 2023Nationwide• Accord Healthcare, Inc.

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