95,083 total recalls in our database
Mallinckrodt Hospital Products
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
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.
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
CGMP Deviations: Out of specification for residual solvents.
Neptune Resources
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
CGMP Deviations
CGMP Deviations: Potential Glass and Silicone particulates in product
Mallinckrodt Hospital Products
cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.
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.
Labeling: Incorrect or Missing Package Insert
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Chemical Contamination; presence of benzene.
Neptune Resources
Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.
CGMP Deviations: potential presence of Burkholderia cepacia complex
Henry Schein Inc. and Glove Club HSI Gloves
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Today The World
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.
Today The World
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.
Cardinal Health 200
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Cardinal Health 200
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.