Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
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Class II · Moderate risk
dexmedeTOMIDine HCl PF
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
Glycopyrrolate
Lack of Assurance of Sterility: Leaking/damaged syringes.
Class II · Moderate risk
0.9% Sodium chloride Irrigation USP
Presence of Particulate Matter
Class II · Moderate risk
Unisom
CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Class II · Moderate risk
Clindamycin HCl
CGMP Deviations
Class II · Moderate risk
Haloperidol Decanoate Injection
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 100mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Haloperidol Decanoate Injection 50mg/mL
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Class II · Moderate risk
Atorvastatin Calcium Tablets USP 40 mg
Failed dissolution specifications: lower than specifications
Class I · High risk
Levetiracetam 0.75% in Sodium Chloride Injection 1
LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules
CGMP Deviations
Class II · Moderate risk
Propafenone Hydrochloride Extended-Release Capsules USP
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Pravastatin Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Cetirizine Hydrochloride Tablets
CGMP Deviations
Class II · Moderate risk
Acetaminophen and Ibuprofen
CGMP Deviations
Class II · Moderate risk
Naproxen Sodium Tablets
CGMP Deviations
Class II · Moderate risk
Saxagliptin Tablets
CGMP Deviations
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
CGMP Deviations
Class II · Moderate risk
Lacosamide Tablets 150mg
CGMP Deviations
Class II · Moderate risk
Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg
CGMP Deviations