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Showing 4941–4960 of 14370 results

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Pre-Tat Lidocaine Gel (Ridge Properties) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Class IIModerate

FDAAug 9, 2019Nationwide• Ridge Properties, LLC

Pre-Tat Lidocaine Cream (Ridge Properties) – Microbial Contamination (2019)

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

Class IIModerate

FDAAug 9, 2019Nationwide• Ridge Properties, LLC

Superior Pain Relief Gel (Ridge Properties) – Superpotent Drug (2019)

Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.

Class IIModerate

FDAAug 9, 2019Nationwide• Ridge Properties, LLC

Vivitrol Injection (Alkermes) – Incorrect Needle Labeling (2019)

Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

Class IIModerate

FDAAug 8, 2019Nationwide• Alkermes Inc

Clotrimazole Betamethasone Cream (Glenmark) – Temperature Abuse (2019)

Temperature Abuse: Complaints received of liquidy texture.

FDAAug 7, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Eptifibatide Injection (Akorn) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

FDAAug 6, 2019Nationwide• Akorn, Inc.

Eptifibatide Injection (Akorn) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

FDAAug 6, 2019Nationwide• Akorn, Inc.

Eptifibatide Injection (Akorn) – Short Fill Issue (2019)

Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

FDAAug 6, 2019Nationwide• Akorn, Inc.

Lisinopril/HCTZ Tablets (RemedyRepack) – Foreign Tablet Presence (2019)

Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.

Class IIModerate

FDAAug 5, 2019PA• RemedyRepack Inc.

Simvastatin Tablets (Aurobindo Pharma) - Incorrect Lot Number (2019)

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

FDAJul 29, 2019Nationwide• Aurobindo Pharma USA Inc.

Bexarotene Capsules (Upsher Smith) – Dissolution Failure (2019)

Failed Dissolution Specifications

Class IIModerate

FDAJul 29, 2019KY, LA, NJ +1 more• Upsher Smith Laboratories, Inc.

Papav/Phentol/PGE1 Injection (Colonia Care) – sterility risk (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

Nitrofurantoin Capsules (Alvogen) - Dissolution Failure (2019)

Failed dissolution specifications

Class IIModerate

FDAJul 24, 2019PR• Alvogen, Inc

C-Methylcobalamin Injection (Colonia Care) - Sterility Concerns (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

Macrobid Urinary Tract Antibacterial (Alvogen) – Failed Dissolution (2019)

Failed dissolution specifications

Class IIModerate

FDAJul 24, 2019PR• Alvogen, Inc

C-Papav/Phentol/PGE1 Injection (Colonia Care) – Sterility Concern (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

C-Papav/Phentol/PGE1 Injection (Colonia Care) – Sterility Concern (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

C-Dexamethasone Injection (Colonia Care) – Sterility Concern (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

C-Cromolyn Sodium Inhalation (Colonia Care) – Sterility Concern (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

C-Atropine Sulfate Ophthalmic (Colonia Care) – Sterility Concern (2019)

Lack of Assurance of Sterility: product sterility cannot be guaranteed.

Class IIModerate

FDAJul 24, 2019IN, NJ• Colonia Care Pharmacy

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