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Showing 5441–5460 of 14454 results

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Lidocaine HCl Injection (Aurobindo) – Particulate Contamination (2019)

Presence of Particulate Matter: One vial was found to contain a hair.

FDAMar 28, 2019IN, NM, NC• Aurobindo Pharma USA Inc.

Thallous Chloride Injection (GE Healthcare) – Chemical Contamination (2019)

Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.

FDAMar 26, 2019Nationwide• Medi-Physics Inc. dba GE Healthcare

Phenobarbital Oral Solution (Lohxa) – Incorrect Expiration Date (2019)

Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.

Class IIModerate

FDAMar 25, 2019MA, NY, WY• Lohxa LLC

Pravastatin Sodium Tablets (Glenmark) – Foreign Tablet Found (2019)

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

Class IIModerate

FDAMar 25, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Biotin Injection (Auro Pharmacies) – pH Specification Failure (2019)

Failed pH Specification: product does not meet pH label claim.

FDAMar 22, 2019Nationwide• Auro Pharmacies Inc. DBA Central Drugs

Fayosim Birth Control (Lupin) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.

Class IIModerate

FDAMar 22, 2019Nationwide• Lupin Pharmaceuticals Inc.

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Gavilyte-N (Lupin Somerset) – Incorrect Flavor Labeling (2019)

Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient

Class IIModerate

FDAMar 19, 2019Nationwide• LUPIN SOMERSET

Combigan Eye Solution (Allergan) – Manufacturing Deviation (2019)

cGMP Deviations

Class IIModerate

FDAMar 19, 2019TN• Allergan Sales, LLC

Probiotic Capsules (Walgreens) – incorrect strain (2019)

Incorrect probiotic strain used in formulation which did not match product labeling.

FDAMar 19, 2019Nationwide• Merical, LLC

Diclofenac Sodium Solution (Ingenus) – Leaking Bottles (2019)

Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.

FDAMar 18, 2019Nationwide• Ingenus Pharmaceuticals Llc

Sodium Bicarbonate Injection (Pfizer) – Glass Particulates (2019)

Presence of Particulate Matter; glass particulates

FDAMar 15, 2019Nationwide• Pfizer Inc.

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

Clindamycin Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

Cleocin Phosphate Injection (Pfizer) – Impurity Specification Failure (2019)

Failed Impurities/Degradation Specifications: High out-of-specification (OOS) results were demonstrated for several specified impurities at the 24-month time point

FDAMar 15, 2019Nationwide• Pfizer Inc.

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