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Krazy Night (Ummzy) - Undeclared Ingredients (2021)

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Class IHigh

FDAMar 30, 2021Nationwide• Ummzy, LLC

PremierZen Platinum 5000 (Na Na) - Undeclared Ingredients (2021)

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.

Class IIModerate

FDAMar 30, 2021

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Krazy Night (Ummzy) - Undeclared Ingredients (2021)

PremierZen Platinum 5000 (Na Na) - Undeclared Ingredients (2021)

Thumbs Up 7 Red (Ummzy) - Undeclared Ingredients (2021)

69MODE Blue 69 (Nuri Trading) - Undeclared Ingredients (2021)

Shogun-X 7000 (Nuri Trading) - Undeclared Ingredients (2021)

Lidocaine Ointment (Teligent) - Failed Stability (2021)

Thumbs Up 7 Black (Nuri Trading) - Undeclared Ingredients (2021)

Thumbs Up 7 White (Nuri Trading) - Undeclared Ingredients (2021)

Cefprozil Oral Suspension (Lupin) – Superpotent Drug (2021)

PremierZen Black 5000 Capsules (Namoo) – Unapproved Drug Ingredients (2021)

Metformin HCl Extended-Release Tablets (Sun Pharma) – Moisture Limits Failure (2021)

Imperial Extreme 2000 Capsules (S & B Story) – Unapproved Drug Ingredients (2021)

Mometasone Furoate Topical Solution (Cosette) – CGMP Deviations (2021)

Thumbs Up 7 Blue 69K (Bit & Bet) – Unapproved Drug Ingredients (2021)

TRESIBA FlexTouch (Novo Nordisk) – Temperature Storage Issue (2021)

TRESIBA FlexTouch 200 (Novo Nordisk) – Temperature Storage Issue (2021)

Fiasp FlexTouch (Novo Nordisk) – Temperature Storage Issue (2021)

NovoLog Insulin (Novo Nordisk) – Temperature Storage Issue (2021)

Fiasp PenFill (Novo Nordisk) – Temperature Storage Abuse (2021)

TRESIBA Insulin (Novo Nordisk) – Temperature Storage Abuse (2021)