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T-106 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide• Olympia Compounding Pharmacy dba Olympia Pharmacy

Sermorelin Acetate (Olympia) - CGMP Monitoring Issues (2022)

CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated

Class IIModerate

FDAApr 4, 2022Nationwide

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T-106 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

Sermorelin Acetate (Olympia) - CGMP Monitoring Issues (2022)

Diluent Reconstitution Solution (Olympia) - CGMP Monitoring Issues (2022)

AT-6 Papaverine Phentolamine (Olympia) - CGMP Monitoring Issues (2022)

Testosterone Cypionate (Olympia) - CGMP Monitoring Issues (2022)

PGE-3 Alprostadil (Olympia Pharmacy) – CGMP Monitoring Issues (2022)

Cequa Cyclosporine (Sun Pharmaceutical) – Subpotent Medication (2022)

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification (2022)

Esomeprazole Magnesium Capsules (Mylan) – Impurity Specification Failure (2022)

Travoprost Ophthalmic Solution (Mylan) – Subpotent Medication (2022)

Methylprednisolone Tablets (Jubilant Cadista) – Subpotent Medication (2022)

CBD Metered Dose Inhaler (Wellness BioSciences) – Unapproved Drug (2022)

Sodium Chloride Injection (Ritedose) – Incorrect Barcode (2022)

Losartan/Hydrochlorothiazide 100/12.5mg (Lupin) – AZIDO Impurity Excess (2022)

Losartan/Hydrochlorothiazide 50/12.5mg (Lupin) – AZIDO Impurity Excess (2022)

Losartan Potassium Tablets 50mg (Lupin) – AZIDO Impurity Excess (2022)

Janumet Tablets 50/500mg (Merck) – Stainless Steel Particulates (2022)

Losartan Potassium Tablets 100mg (Lupin) – AZIDO Impurity Excess (2022)

Losartan Potassium Tablets 25mg (Lupin) – AZIDO Impurity Excess (2022)

Losartan/Hydrochlorothiazide 100/25mg (Lupin) – AZIDO Impurity Excess (2022)