Class II · Moderate risk
Lorazepam 1 mg/mL Infusion Solution in 250 mL bags
Lack of Assurance of Sterility
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
Ketamine 50 mg Infusion
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 6 mg/mL Infusion in 250 mL bag
Lack of Assurance of Sterility
Class II · Moderate risk
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Command Brands GelAnti Bac Instant Hand Sanitizer
CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk
Day & Night Pack Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops with 4% Lidocaine
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops For Kids
cGMP Deviations.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent drug: Out of specification for assay at the 15-month test interval.
Class II · Moderate risk
Leiper's Fork Distillery
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Class II · Moderate risk
Jaloma Antiseptic Hand Sanitizer
cGMP deviations
Class II · Moderate risk
Hand Sanitizer
Discoloration and Presence of Foreign Substance
Class II · Moderate risk
Next Advanced Antibacterial Hand Sanitizer
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Assured Instant Hand Sanitizer Vitamin E and Aloe
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Assured Instant Hand Sanitizer Aloe & Moisturizers
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.