Class II · Moderate risk
Clear Eyes
Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.
FDA Drug Recalls
948 recalls · Class II, newest first
Class II · Moderate risk
NaturalCare
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NatraBio
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
NaturalCare bioAllers
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class II · Moderate risk
Carbidopa and Levodopa Tablets
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class II · Moderate risk
Sterile Water for Injection
CGMP Deviations: Potential product carryover.
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Phenylephrine HCl in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Diltiazem HCl in 0.7% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Phenylephrine HCl 20 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 40 mg
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 1mg per 10mL
CGMP DEVIATIONS
Class II · Moderate risk
Phenylephrine HCl 0.5 mg per 5 mL
CGMP DEVIATIONS
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk
Warfarin Sodium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Purely Soothing MSM Nasal Spray
CGMP Deviations
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the possibility of an incomplete seal that may cause leakage. The impacted lots may exhibit microscopic channel leaks near the port assembly of the product.