Ibuprofen Tablets
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards.
1,754 FDA drug recalls with this cause, newest first.
This category covers departures from current Good Manufacturing Practice during production. It is FDA's broadest label, used when a facility's own process control failed somewhere along the line even if no single ingredient was proven unsafe on its own. Where the report names a specific consequence - a temperature excursion, a contaminant, a potency problem - we file the recall under that more specific cause instead; what remains here is the genuinely general case.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications.
CGMP deviations: Ibuprofen is being recalled in response to previous recall
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
CGMP Deviations: Market complaints related to "gritty texture".
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
GMP Deviations: inadequate manufacturing control processes
cGMP Deviations: lack of quality assurance at the API manufacturer.
CGMP Deviations
Incorrect Product Formulation: product contains dexamethasone instead of hydrocortisone.
CGMP Deviations
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