Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Only, Sterile, 10 Vials, Teva Pharmaceuticals, USA, Inc., North Wales, PA NDC 00703-7121-03
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
💊 Drugs • 11,927 recalls
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
SigmaPharm Laboratories
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Subpotent Drug
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil.
SigmaPharm Laboratories
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Failed Impurities/Degradation Specifications
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Subpotent and Presence of Particulates .
Preferred Pharmaceuticals
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Presence of foreign substance: identified as activated carbon.
Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 count, included in Health Essential Kits, labeled incorrectly with a prescription drug label instead of an OTC drug label.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and/or sildenafil.
Heritage Pharmaceuticals
Labeling: Incorrect or Missing Lot and/or Exp Date