Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
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
Heparin Sodium 5
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk
Herbacil
CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Phentermine HCL Blue Speckled tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL White/Blue Speckled tablets
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL White/Blue Speck Tabs 37.5 mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL Blue/White Capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL Blue/Clear capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL Yellow Caps 30mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL GrayYellow capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine 15mg grey/Yellow Capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phentermine HCL Gray/Yellow capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phendimetrazine Brown/Clear Capsules
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
Class II · Moderate risk
Phendimetrazine Yellow Tabs 35mg
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.