Class II · Moderate risk
Lanashield Skin Barrier
cGMP deviations
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
Dr. Bump Natural Pain Relief Gel
CGMP Deviations
Class II · Moderate risk
Clearstem You Are Sunshine Spf 50
CGMP Deviations
Class II · Moderate risk
Elixir by Coco March Tinted Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Elixir by Coco March Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Sugared+Bronzed Tinted Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Karina Daily Moisturizer SPF 25
CGMP Deviations
Class II · Moderate risk
Gabriel Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Sea Enzyme Ultra Umbrella Sunscreen SPF 30
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Cream
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Controlling Balm with Tea Tree Oil
CGMP Deviations
Class II · Moderate risk
Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50
CGMP Deviations
Class II · Moderate risk
Doctor. D. Schwab Mineral Sunscreen SPF 50
CGMP Deviations
Class II · Moderate risk
Sucralfate Tablets
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 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
Fentanyl citrate
CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Market complaints received for gritty texture (grainy)
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class II · Moderate risk
Neuroquell & Neuroquell Plus
cGMP violations
Class II · Moderate risk
UltraSure Anti-Perspirant & Deodorant
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
San-E-Foam
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew Skin Repair Cream
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
Renew PeriProtect
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
Class II · Moderate risk
PeriGuard Ointment
CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.
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