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Waterless Hand Sanitizer (Inopak Ltd) – Manufacturing Deviation (2019)

CGMP Deviations: hand sanitizers and soaps were not produced under current good manufacturing practices.

FDAApr 22, 2019Nationwide• Inopak Ltd

Fentanyl Transdermal System (Alvogen) – Product Mix-Up (2019)

Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.

Class IHigh

FDAApr 19, 2019Nationwide• Alvogen, Inc

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Waterless Hand Sanitizer (Inopak Ltd) – Manufacturing Deviation (2019)

Fentanyl Transdermal System (Alvogen) – Product Mix-Up (2019)

Bevacizumab Injection (Pacifico National) – Delivery System Issue (2019)

California Orange Blossom Honey (Glorybee) – unapproved antibiotic (2019)

Losartan/Hydrochlorothiazide Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Potassium Tablets (Torrent Pharma) – NMBA Impurity (2019)

Losartan Potassium Tablet (Torrent Pharma) – Impurity Detection (2019)

Losartan Hydrochlorothiazide Tablets (Torrent Pharma) – NMBA Impurity (2019)

Volumex Injection (Iso-Tex) – Sterility Concerns (2019)

Oxytocin Bag (CMC Enterprise) – Sterility Risk (2019)

Phenylephrine Bag (CMC Enterprise) – Sterility Risk (2019)

Ceftriaxone Injection Syringe (CMC Enterprise) – Sterility Concern (2019)

Magnesium Sulfate Bag (CMC Enterprise) – Sterility Risk (2019)

Amoxicillin Suspension (Teva) – Subpotent Product (2019)

Lidocaine Sodium Bicarbonate Syringe (CMC Enterprise) – Sterility Risk (2019)

Vancomycin Bag (CMC Enterprise) – Sterility Risk (2019)

Phenylephrine NS Syringe (CMC Enterprise) – Sterility Problem (2019)

Vancomycin NS Bag (CMC Enterprise) – Sterility Problem (2019)