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Showing 6041–6060 of 15081 results

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Probiotic Capsules (Walgreens) – incorrect strain (2019)

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

FDAMar 19, 2019Nationwide• Merical, LLC

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

cGMP Deviations

Class IIModerate

FDAMar 19, 2019TN• Allergan Sales, 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.

Class IIILow

FDAMar 18, 2019Nationwide• Ingenus Pharmaceuticals Llc

Repairwear Laser Focus Cream (Estee Lauder) – Ineffective Seal (2019)

Defective container: Ineffective seal between the cap and jar of the affected product.

FDAMar 15, 2019Nationwide• Estee Lauder Inc

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

Presence of Particulate Matter; glass particulates

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.

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.

Losartan Tablets (RemedyRepack) – Unexpected Impurity (2019)

CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).

Class IIModerate

FDAMar 14, 2019FL• RemedyRepack Inc.

Blue Fusion Capsules (Ata International) – Undeclared Ingredients (2019)

Laceration Risk

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared ingredients: Sildenafil, Tadalafil, desmethyl carbodenafil, dithiodesmethyl carbodenafil, scutellarin, and daidzein.

FDAMar 14, 2019Nationwide• Ata International Inc

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Glycopyrrolate Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Lidocaine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Phenylephrine HCl Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

Morphine Sulfate Injectable Solution (Advanced Pharma) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAMar 13, 2019Nationwide• Advanced Pharma Inc.

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