Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed-Release Tablets
Reason Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Phenobarbital Oral Solution
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk Terminated
Bismuth Subsalicylate Oral Suspension 262mg/15mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
Class II · Moderate risk Terminated
Pravastatin Sodium Tablets USP
Reason Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter.
Class II · Moderate risk Terminated
Fayosim
Reason Failed Impurities/Degradation Specifications: Out-of-specification results observed in related substance test (Any Other Individual Impurity and Total impurities) in Ethinyl Estradiol Tablets USP 0.01mg at 12 month long term stability study.
Class II · Moderate risk Terminated
Gavilyte-N
Reason Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk Terminated
Combigan
Reason cGMP Deviations
Class II · Moderate risk Terminated
Losartan 50mg Tablet
Reason CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 30 mg/30 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Esmolol HCl Injectable Solution 100 mg/10 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
2% Lidocaine HCl Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
2% Lidocaine HCl Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate 0.6 mg/3 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Neostigmine Methylsulfate Injection Solution 5 mg/5mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Glycopyrrolate Injectable Solution 1 mg/5 mL
Reason Lack of Assurance of Sterility