Class II · Moderate risk Terminated
Hand Sanitizer
Reason Discoloration and Presence of Foreign Substance
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Next Advanced Antibacterial Hand Sanitizer
Reason 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 Ongoing
Assured Instant Hand Sanitizer Vitamin E and Aloe
Reason 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 Ongoing
Assured Instant Hand Sanitizer Aloe & Moisturizers
Reason 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 Ongoing
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera
Reason 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 Ongoing
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER
Reason 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 Terminated
Heparin Sodium 5
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk Terminated
Herbacil
Reason CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk Completed
HAND SANITIZER Non-sterile Solution 70% Topical Solution
Reason cGMP deviations
Class II · Moderate risk Completed
Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol
Reason cGMP deviations
Class II · Moderate risk Terminated
Phentermine HCL Blue Speckled tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL White/Blue Speckled tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL White/Blue Speck Tabs 37.5 mg
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL Blue/White Capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL Blue/Clear capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL Yellow Caps 30mg
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL GrayYellow capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine 15mg grey/Yellow Capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phentermine HCL Gray/Yellow capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phendimetrazine Brown/Clear Capsules
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phendimetrazine Yellow Tabs 35mg
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Phendimetrazine Yellow Tabs 35mg
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Topiramate 25mg Tabs White/round tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Thyroid Neutral Tabs 2 gr
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk Terminated
Thyroid 1 Gr tablets
Reason CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.