Class II · Moderate risk
Blood Culture Prep Kit II containing 1 FREPP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
FDA Drug Recalls
1,803 recalls · Class II, newest first
Class II · Moderate risk
SEPP 10% Povidone Iodine Solution USP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
SEPP 2% Iodine Tincture USP
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
SEPP 70% Isopropanol
Labeling: Not Elsewhere Classified: This product is misbranded because the product is not sterile and the labeling is misleading in relation to sterility claims.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Class II · Moderate risk
Rifadin (rifampin)
Subpotent Drug: During review of retain samples, the manufacturer observed low fill in some capsules, which was related to an issue detected with the encapsulating equipment.
Class II · Moderate risk
Sodium Acetate Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
QUELICIN (succinylcholine chloride)
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Furosemide Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Diazepam Injection
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Class II · Moderate risk
Cefdinir for Oral Suspension
Defective Container: This recall is being carried out due to the potential for improperly sealed bottles.
Class II · Moderate risk
Propofol Injectable Emulsion
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
Class II · Moderate risk
Fludeoxyglucose F 18 Injection USP
cGMP Deviation
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrectly released without meeting product specifications. There is the potential for the solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
Amoxicillin for Oral Suspension
Microbial Contamination of Non-Sterile Products: Suspensions made from these lots of Amoxicillin 125 mg/5 mL showed yeast and mold growth at the 14 day time point.
Class II · Moderate risk
METRONIDazole Injection
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Class II · Moderate risk
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Class II · Moderate risk
0.9% Sodium Chloride Irrigation
Lack of Assurance of Sterility: There is a potential for the solution to leak from the administration port of the primary container.
Class II · Moderate risk
Pantoprazole Sodium Delayed Release Tablets USP
cGMP Deviations: Oral products were not manufactured in accordance with Good Manufacturing Practices.
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class II · Moderate risk
Meprobamate
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate because an out of specification result for an impurity diphenyl sulfone .
Class II · Moderate risk
CLONAZEPAM ORALLY DISINTERGRATING Tablets
Failed Content Uniformity Specifications: Recall is being carried out due to an out-of-specification result for content uniformity.
Class II · Moderate risk
Ciprofloxacin Tablets USP
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Class II · Moderate risk
Benjamins Infants Gripe Mixture
CGMP Deviations: this product is being recalled because an FDA inspection revealed that it was not manufactured under current good manufacturing practices.
Class II · Moderate risk
Daytrana (methylphenidate)
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.