Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Diltiazem HCl in 0.7% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl 20 mg
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 40 mg
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 1mg per 10mL
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Phenylephrine HCl 0.5 mg per 5 mL
Reason CGMP DEVIATIONS
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class II · Moderate risk Terminated
Warfarin Sodium Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Purely Soothing MSM Nasal Spray
Reason CGMP Deviations
Class II · Moderate risk Completed
0.9% Sodium Chloride Injection
Reason 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 Completed
0.9% Sodium Chloride Injection
Reason 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 Terminated
Allergy Relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Picnic
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergy relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergyrelief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Fexofenadine Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
allergy relief
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Allergy ALLER-FEX
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
aller-ease
Reason Failed Impurities/Degradation Specifications