Maximum Strength Acid Reducer
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
11,818 recalls · Class II, newest first
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine.
Presence of Foreign Substance
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Marketed without an Approved NDA/ANDA
Failed Dissolution Specification: Low out of specification dissolution results.