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Losartan Potassium Tablets (Torrent) – NDEA Impurity (2018)

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.

Class IIModerate

FDADec 20, 2018Nationwide• Torrent Pharma Inc.

Ozurdex Implant (Allergan) – Silicone Particulate (2018)

GMP Deviations: A silicone particulate was noted in Ozurdex.

Class IIModerate

FDADec 20, 2018Nationwide• Allergan, PLC.

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Losartan Potassium Tablets (Torrent) – NDEA Impurity (2018)

Ozurdex Implant (Allergan) – Silicone Particulate (2018)

Ceftriaxone Injection (Lupin) – Rubber Particulate Matter (2018)

Temozolomide Capsules (Amerigen) – Failed Dissolution (2018)

Losartan Potassium Tablets (Torrent) – NDEA Impurity (2018)

Cosopt Ophthalmic Solution (Akorn) – Failed Stability Test (2018)

Women's Iron Complete Supplements (GNC) – Safety Closure Issue (2018)

Oxygen Liquid (Roberts Home Medical) – CGMP Deviations (2018)

Olmesartan/Hydrochlorothiazide Tablets (Teva) – Failed Dissolution (2018)

Cidofovir Dihydrate (LGM Pharma) – FDA Import Alert (2018)

HCG Injection (Promise Pharmacy) – Sterility Risk (2018)

Nicotinamide Adenine Dinucleotide (Promise Pharmacy) – sterility risk (2018)

Ipamorelin Injection (Promise Pharmacy) – Sterility Concerns (2018)

Epithalon Injection (Promise Pharmacy) – Sterility Concerns (2018)

Ascorbic Acid Injection (Promise Pharmacy) – sterility risk (2018)

Dexpanthenol Injection (Promise Pharmacy) – Sterility Concerns (2018)

Folic Acid Injection (Promise Pharmacy) – Sterility Concerns (2018)

Sermorelin Injection (Promise Pharmacy) – Sterility Risk (2018)

Lysine HCl Injection (Promise Pharmacy) – Sterility Concerns (2018)

Zinc Sulfate Injection (Promise Pharmacy) – Sterility Risk (2018)