Class II · Moderate risk
alba BOTANICA sport mineral sunscreen
Incorrect Product Formulation: wrong sunscreen product in the package.
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
Monsel's Solution
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Acetylcysteine for Injection 6 g/30 mL
CGMP Deviations
Class II · Moderate risk
Monsel's Solution
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Class II · Moderate risk
MD Complete Clarifying Cleanser
GMP Deviations
Class II · Moderate risk
Naturmetic SPF 50 Sunscreen
GMP Deviations
Class II · Moderate risk
Solar Defense Sheer Sunscreen Broad Spectrum SPF50
GMP Deviations
Class II · Moderate risk
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Loxapine Capsules
CGMP Deviations
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk
Amlodipine and Benazapril HCL Capsules
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class III · Low risk
Class II · Moderate risk
Lupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
Class II · Moderate risk
Kisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
OPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Tasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Zarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Lack of Processing Controls.
Class II · Moderate risk
Perjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Lack of Processing Controls.
Class II · Moderate risk
Letrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Lack of Processing Controls.
Class II · Moderate risk
Ondansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Bendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Lack of Processing Controls.
Class II · Moderate risk
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and…
Lack of Processing Controls.
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