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Irinotecan Injection (West-Ward) – Superpotent Drug Calculation (2013)

Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.

Class IIModerate

FDASep 23, 2013Nationwide• West-Ward Pharmaceutical Corp.

Next Choice Emergency Contraceptive (Watson) – Tablet Breakage (2013)

Failed Tablet/Capsule Specifications: Multiple complaints for push through tablet breakage.

Class IIModerate

FDASep 23, 2013Nationwide

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Irinotecan Injection (West-Ward) – Superpotent Drug Calculation (2013)

Next Choice Emergency Contraceptive (Watson) – Tablet Breakage (2013)

Ketoconazole Shampoo (Tolmar) – Subpotent Formulation (2013)

Irinotecan Injection (West-Ward) – Superpotent Drug Calculation (2013)

Acanya Gel (Valeant) – Incorrect Expiration Date (2013)

GABA Supplement (Source Naturals) – metal fragment risk (2013)

Endometrin Vaginal Insert (Ferring) – Heat Discoloration (2013)

Quinapril Tablets (Lupin) – Impurity Specification Failure (2013)

Amlodipine Tablets 2.5mg (Mylan) – Manufacturing Deviation (2013)

Prolia Injection (Amgen) – Particulate Matter Concern (2013)

Amlodipine Tablets 5mg (Mylan) – Manufacturing Deviation (2013)

Quinapril Tablets (Lupin) – Impurity Specification Failure (2013)

Amlodipine Tablets 10mg (Mylan) – Manufacturing Deviation (2013)

Lidocaine Injection (Hospira) – Particulate Matter Found (2013)

Morphine Sulfate Injection (Hospira) – Sterility Concern (2013)

Venlafaxine Tablets (Osmotica) – Dissolution Specification Failure (2013)

Omeprazole Capsules (Kremers) – Acid Resistance Issue (2013)

Amlodipine Besylate Tablets (Mylan) – Manufacturing Deviation (2013)

Amlodipine Benazepril Capsules (Mylan) – Manufacturing Deviation (2013)

Amlodipine Besylate and Benazepril HCl Capsules (Mylan) – Manufacturing Deviation (2013)