Class II · Moderate risk
Olopatadine HCl Ophthalmic Solution
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
Ofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Neomycin and Polymyxin B Sulfates
CGMP Deviations:
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
CGMP Deviations:
Class II · Moderate risk
Levofloxacin Ophthalmic Solution 0.5%
CGMP Deviations:
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
GONAK Hypromellose Ophthalmic Demulcent Solution
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP
CGMP Deviations:
Class II · Moderate risk
Erythromycin Ophthalmic Ointment USP 0.5%
CGMP Deviations:
Class II · Moderate risk
Cromolyn Sodium Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Ciprofloxacin Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Betaxolol Ophthalmic Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears Solution
CGMP Deviations:
Class II · Moderate risk
Artificial Tears OINTMENT
CGMP Deviations:
Class II · Moderate risk
Class III · Low risk
oxyTOCIN 30 Units/500 mL
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Triamcinolone Acetonide cream
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Triamcinolone Acetonide Cream USP
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations;
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Magnesium Citrate SALINE LAXATIVE
CGMP Deviations
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
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