Class II · Moderate risk Ongoing
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100
Reason cGMP Deviations
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena Beach Defense water + sun protection sunscreen spray…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena COOLDRY SPORT sunscreen spray SPF 30
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60
Reason cGMP Deviations
Class II · Moderate risk Terminated
QiYu Hand Sanitizer
Reason Subpotent
Class II · Moderate risk Completed
Compounded Lyophilized AOD-9604
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Sulfamethoxazole and Trimethoprim Tablets
Reason Presence of Foreign Substance- Potential of metal contamination.
Class II · Moderate risk Terminated
NIFEdipine EXTENDED-RELEASE TABLETS
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk Terminated
MIC+Methyl B12 injection Methionine Inositol…
Reason Lack of processing controls
Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Global Hand Sanitizer with moisturizer
Reason CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk Terminated
Zyprexa Intramuscular
Reason cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk Terminated
Xylocaine-MPF with Epinephrine 1:200
Reason Low out of specification results for epinephrine assay.
Class II · Moderate risk Ongoing
QiYu Hand Sanitizer
Reason Subpotent
Class II · Moderate risk Terminated
Acetaminophen 325 mg tablets
Reason cGMP deviations: Discolored acetaminophen
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit