Class II · Moderate risk
Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Manufacturing (cGMP) deviations
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.
Class II · Moderate risk
Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol
Lack of Processing Controls.
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II · Moderate risk
Shave and Skincare Power Stick Original Nourishing Invisible…
CGMP Deviations
Class II · Moderate risk
Beauty & Skincare Power Stick original nourishing invisible…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Peripheral Parenteral Nutrition
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
Class II · Moderate risk
Phentermine Hydrochloride Capsules
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class II · Moderate risk
temper tamer
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint Anticavity Fluoride Toothpaste
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Nature Mint
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security
CGMP Deviations
Class II · Moderate risk
Maximum Security Anticavity Gel Toothpaste
CGMP Deviations
Class II · Moderate risk
Cinnafresh anticavity gel toothpaste
CGMP Deviations
Class II · Moderate risk
Rapidol
CGMP Deviations
Class II · Moderate risk
Rapidol Maximum Strength
CGMP Deviations
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