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Showing 3861–3880 of 14370 results

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Daytrana 30mg (Noven) – Delivery System Defect (2021)

Defective Delivery System: Out of specification for mechanical peel.

Class IIModerate

FDAFeb 19, 2021Nationwide• Noven Pharmaceuticals Inc

Daytrana 20mg (Noven) – Delivery System Defect (2021)

Defective Delivery System: Out of specification for mechanical peel.

Class IIModerate

FDAFeb 19, 2021Nationwide• Noven Pharmaceuticals Inc

Acyclovir Sodium 1000mg (Zydus) – Product Crystallization (2021)

Crystallization: customer complaints for crystallization in finished product.

Class IHigh

FDAFeb 18, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Acyclovir Sodium 500mg (Zydus) – Product Crystallization (2021)

Crystallization: customer complaints for crystallization in finished product.

FDAFeb 18, 2021Nationwide• Zydus Pharmaceuticals (USA) Inc

Fludeoxyglucose F 18 (General Hospital) – Sterility Concern (2021)

Lack of Assurance of Sterility

Class IIModerate

FDAFeb 17, 2021Nationwide• The General Hospital Corporation

Imatinib Mesylate 100mg (Dr. Reddy's) – Dissolution Issue (2021)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 17, 2021Nationwide• Dr. Reddy's Laboratories, Inc.

Metoclopramide Injection (Teva) – Chemical Contamination (2021)

Chemical contamination; Unknown brown residue adhering to the inside of one vial.

Class IIModerate

FDAFeb 15, 2021Nationwide• Teva Pharmaceuticals USA

Metoclopramide Injection (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Methylprednisolone Acetate (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Epoprostenol Sodium (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Vecuronium Bromide (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Leucovorin Calcium (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Methylprednisolone Acetate (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Methylprednisolone Acetate (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Epoprostenol Sodium (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Dacarbazine Injection (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Methylprednisolone Acetate (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Leucovorin Calcium (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Toposar Etoposide (Teva) – sterility risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

Epoprostenol Diluent (Teva) – Sterility Risk (2021)

Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.

Class IIModerate

FDAFeb 10, 2021Nationwide• Teva Pharmaceuticals USA

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