Class II · Moderate risk
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray SPF 30
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class II · Moderate risk
Compounded Lyophilized AOD-9604
Lack of Assurance of Sterility
Class II · Moderate risk
Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous…
Lack of Assurance of Sterility
Class II · Moderate risk
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance- Potential of metal contamination.
Class II · Moderate risk
NIFEdipine EXTENDED-RELEASE TABLETS
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk
MIC+Methyl B12 injection Methionine Inositol…
Lack of processing controls
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Global Hand Sanitizer with moisturizer
CGMP Deviations: Does not meet monograph for denaturant.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk
Xylocaine-MPF with Epinephrine 1:200
Low out of specification results for epinephrine assay.
Class II · Moderate risk
QiYu Hand Sanitizer
Subpotent
Class II · Moderate risk
Acetaminophen 325 mg tablets
cGMP deviations: Discolored acetaminophen
Class II · Moderate risk
Solifenacin Succinate Tablets
CGMP Deviations
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class II · Moderate risk
QiYu Hand Sanitizer Gel
Subpotent
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
DermOtic Oil
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.