Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Cephalexin for Oral Suspension
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Class II · Moderate risk
Lidocaine/Tetracaine
Superpotent Drug. Lidocaine higher concentration than listed
Class II · Moderate risk
Famotidine Tablets USP 40mg
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Class II · Moderate risk
Nortriptyline HCl Capsules
CGMP deviations.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Sulfur Ointment 10%
Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk
Metformin Hydrochloride Extended-Release Tablets
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk
Chlorhexidine Gluconate Oral Rinse USP 0.12%
cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk
Acetaminophen Injection 1
Discoloration and failed pH specifications
Class II · Moderate risk
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Labeling: Missing instructions for use insert
Class II · Moderate risk
Paroex (Chlorhexidine Gluconate)
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class II · Moderate risk
Levetiracetam Oral Solution
Defective container: Customer complaints for oral solution leaking from bottles.
Class II · Moderate risk
IMC Wash-Free Hand Sanitizer
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
IMC Wash-Free Hand Sanitizer
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
IMC Wash-Free Hand Sanitizer
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
Zerbaxa (ceftolozane and tazobactam)
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
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9%
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
fentaNYL 100 mcg/2mL Injection for IV or IM Use
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
SUCcinylcholine Chloride 100 mg/5mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk
Rocuronium Br 50 mg/5mL
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit