Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Lidocaine/Tetracaine
Reason Superpotent Drug. Lidocaine higher concentration than listed
Class II · Moderate risk Terminated
Famotidine Tablets USP 40mg
Reason Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class II · Moderate risk Terminated
Nortriptyline HCl Capsules
Reason CGMP deviations.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Sulfur Ointment 10%
Reason Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk Terminated
Chlorhexidine Gluconate Oral Rinse USP 0.12%
Reason cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk Terminated
Acetaminophen Injection 1
Reason Discoloration and failed pH specifications
Class II · Moderate risk Terminated
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Reason Labeling: Missing instructions for use insert
Class II · Moderate risk Terminated
Levetiracetam Oral Solution
Reason Defective container: Customer complaints for oral solution leaking from bottles.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
Zerbaxa
Reason Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Class II · Moderate risk Terminated
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9%
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
fentaNYL 100 mcg/2mL Injection for IV or IM Use
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 100 mg/5mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Rocuronium Br 50 mg/5mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
SUCccinylcholine Chloride 200 mg/10 mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Sodium Citrate 4% 3 mL Anticoagulation Solution
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit