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Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.

Class IIModerate

FDAFeb 6, 2024Nationwide• Mallinckrodt Hospital Products Inc.

Arize Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Class IHigh

FDA

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Acthar Gel (Mallinckrodt) – Shipping Temperature Issue (2024)

Arize Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

SCHWINNNG Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

TestoFREAK Testosterone Supplement (VRA) – Low Zinc (2024)

Voriconazole Oral Suspension (Lupin) – Labeling Error (2024)

Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Omeprazole Suspension (Bausch Health) – Subpotent Drug (2024)

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

TING Tolnaftate Spray (Insight) – Benzene Contamination (2024)

To the Moon Capsules (Integrity) – Undeclared Sildenafil (2024)

Lansoprazole Capsules (NATCO Pharma) – Inadequate Sealing (2024)

RAM IT Horny Goat Weed Capsules (Integrity) – Undeclared Sildenafil (2024)

Meta Psyllium Fiber Capsules (Procter & Gamble) – Illegible Label (2024)

CVS Health Eye Ointment (Brassica) – Sterility Concern (2024)

Equate Stye Eye Ointment (Brassica) – Sterility Concern (2024)

Lubricant PM Ointment (Brassica) – Sterility Concern (2024)

Equate Eye Ointment (Brassica) – Sterility Concern (2024)

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Febuxostat Tablets (Amerisource) – CGMP Deviation (2024)

Nortrel 7/7/7 Tablets (Teva) – Tablet Discoloration (2024)