Class I · High risk
Lactated Ringer's and 5% Dextrose Injection
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Colloidal Silver
Marketed Without An Approved NDA/ANDA: This product is being recalled because FDA issued a final rule establishing that all over-the-counter (OTC) drug products containing colloidal silver ingredients or silver salts for internal or external use are not generally recognized as safe and effective and are misbranded.
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Report of a vial containing visible particulate matter embedded in the glass wall which has the potential to dislodge resulting in the presence of particulate matter in the product.
Class II · Moderate risk
Moexipril HCl Tablets 7.5mg
Paddock Laboratories, LLC are recalling one lot (2012028142) of Moexipril HCl Tablets 7.5mg (expiration 1/2014) because of a non-conformity dissolution failure result found during routine stability testing at the 6 month test interval.
Class III · Low risk
Lemon Hand Sanitizing Wipes
CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Class III · Low risk
CellCept (mycophenolate mofetil)
Short Fill: some bottles contained less than 120-count per labeled claim.
Class II · Moderate risk
Dr. Reddy's Quetiapine Fumarate Tablets
Failed USP Dissolution Test Requirements: During analysis of long term stability studies at 3 months time point, an OOS was reported for Quetiapine Fumarate Tablets, 25 mg.
Class II · Moderate risk
Cyanocobalamin Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Ondansetron Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Midazolam Hydrochloride Injection
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Class II · Moderate risk
Triamcinolone 10 mg/mL P
Lack of Assurance of Sterility
Class II · Moderate risk
Saline 10% and 3%
Lack of Assurance of Sterility
Class II · Moderate risk
Omnipaque 240mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine 1% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine/Dextrose 5%/7.5% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Isovue 200 mg/mL PF and 300 mg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase 150 u/ml PF
Lack of Assurance of Sterility
Class II · Moderate risk
Glycerin 100% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Dexamethasone Sodium Phosphate 4 mg/mL vials PF
Lack of Assurance of Sterility
Class II · Moderate risk
Clonidine 100 mcg/mL PF
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine 0.25% PF
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Sodium Phosphate 6 mg/mL P Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Betamethasone Repository 6 mg/mL PF Injection and Betamethasone…
Lack of Assurance of Sterility
Class I · High risk
Methylprednisolone Acetate 80 mg/mL Injection
Non-Sterility
Class I · High risk
Methylprednisolone Acetate 40 mg/mL Injection
Non-Sterility