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Showing 5361–5380 of 14370 results

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Pramipexole Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

MethylPREDNISolone Tablets (Zydus) – Cross Contamination Risk (2019)

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class IIModerate

FDAMay 6, 2019Nationwide• Zydus Pharmaceuticals USA Inc

Bevacizumab (Avella) – Sterility Concern (2019)

Lack of assurance of sterility

Class IIModerate

FDAMay 3, 2019Nationwide• Avella of Deer Valley, Inc. Store 38

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 25mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 100mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Losartan Potassium 50mg Tablets (Heritage) – Impurity Detection (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 3, 2019Nationwide• Heritage Pharmaceuticals, Inc.

CVS Children's Fever Liquid (Unipharma) – Bacteria Risk (2019)

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

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

Articaine Dental (Septodont) – Mislabeling Issue (2019)

Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the printed carton are labeled appropriately as Articadent DENTAL.

Class IIModerate

FDAMay 2, 2019Nationwide• Septodont Inc.

Life Rising NECK-ND Neck Clear Capsules (Life Rising) – High Lead (2019)

High lead levels in products

Class IIModerate

FDAMay 2, 2019IN• Life Rising Corporation

DrKids Children's Pain Solution (Unipharma) – Bacteria Risk (2019)

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

Class IIModerate

FDAMay 2, 2019Nationwide• Unipharma, Llc.

Life Rising Holder-W Warmer Capsules (Life Rising) – High Lead (2019)

High lead levels in products

FDAMay 2, 2019IN• Life Rising Corporation

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Losartan Potassium Tablets (Golden State Medical) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAMay 1, 2019IL, MI, MN +3 more• Golden State Medical Supply Inc.

Mycophenolate Mofetil Injection (Par) – Glass Fragment (2019)

Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product

FDAApr 30, 2019Nationwide• Par Pharmaceutical, Inc.

Losartan Potassium Tablets (Preferred Pharmaceuticals) – NMBA Impurity (2019)

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer

Class IIModerate

FDAApr 30, 2019CA, GA, IN +1 more• Preferred Pharmaceuticals, Inc

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