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Showing 781–800 of 1639 results

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Tejocote Root Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product is being recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Terlivaz Injection (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.

Sustain Herbal Supplement (Today The World) – Undeclared Tadalafil (2024)

Undeclared Allergen

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

Class IHigh

FDAFeb 6, 2024Nationwide• Today The World

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.

FDAFeb 6, 2024Nationwide• Today The World

SCHWINNNG 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.

FDAFeb 6, 2024Nationwide• Today The World

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

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAFeb 5, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

HydrALAZINE Tablets (Amerisource) – Impurities Specification (2024)

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

FDAFeb 1, 2024Nationwide• Amerisource Health Services LLC

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

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

FDAFeb 1, 2024Nationwide• Integrity Products

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

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Class IIModerate

FDAFeb 1, 2024Nationwide• NATCO Pharma Limited

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

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

FDAFeb 1, 2024Nationwide• Integrity Products

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

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

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

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

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

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

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

Lack of Assurance of Sterility

Class IIModerate

FDAJan 30, 2024Nationwide• Brassica Pharma Pvt Ltd

Nortrel Tablets (Teva) – Tablet Discoloration (2024)

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

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

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

FDAJan 25, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Norepinephrine Injection (Baxter) – Label Concentration Error (2024)

Incorrect product concentration on the overwrap label: The overwrap label incorrectly identified the product strength as 4 mg / 250 mL; however, the primary bag label correctly identified the product strength as 8 mg / 250 mL.

Class IIModerate

FDAJan 23, 2024Nationwide• Baxter Healthcare Corporation

Vasopressin Injection (IntegraDose) – Sub-potent Drug (2024)

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

Class IIModerate

FDAJan 22, 2024MN• IntegraDose Compounding Services LLC

Glimepiride Tablets 1mg (Dr. Reddy's) – Tablet Misprint (2024)

Misprint on tablet

FDAJan 18, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

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