Class II · Moderate risk Ongoing
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
Reason cGMP Deviations
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Class II · Moderate risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason cGMP Deviations
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class I · High risk Ongoing
Neutrogena Beach Defense water+sun protection sunscreen spray…
Reason Chemical Contamination: presence of benzene
Class II · Moderate risk Ongoing
Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Neutrogena COOLDRY SPORT WITH MICROMESH 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 BROAD SPECTRUM SPF 100
Reason cGMP Deviations
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 I · High risk Ongoing
Vy&Tea
Reason Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
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 III · Low risk Terminated
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer
Reason Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Class I · High risk Terminated
Atovaquone Oral Suspension
Reason Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
Class II · Moderate risk Terminated
NIFEdipine EXTENDED-RELEASE TABLETS
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.