4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
ULTRAtab Laboratories
CGMP Deviations
Prescription and over-the-counter medications
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
Junp Hydration
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
Esupplementsales
Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations
ULTRAtab Laboratories
CGMP Deviations