Class II · Moderate risk Terminated
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Reason Lack of Assurance of Sterility
FDA Drug Recalls
14,801 recalls, newest first
Class II · Moderate risk Terminated
Command Brands GelAnti Bac Instant Hand Sanitizer
Reason CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk Terminated
Day & Night Pack Ear Itch MD Anti-Itch Spray
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Itch MD Anti-Itch Spray
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops with 4% Lidocaine
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Ear Pain MD Pain Relief Drops For Kids
Reason cGMP Deviations.
Class II · Moderate risk Terminated
Nystatin Oral Suspension
Reason Subpotent drug: Out of specification for assay at the 15-month test interval.
Class II · Moderate risk Terminated
Leiper's Fork Distillery
Reason Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Class III · Low risk Terminated
Extra Strength Headache Relief
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk Terminated
Pain Relief Maximum Strength
Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class II · Moderate risk Terminated
Jaloma Antiseptic Hand Sanitizer
Reason cGMP deviations
Class III · Low risk Terminated
Red Cross Oral Pain
Reason Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Class II · Moderate risk Terminated
Hand Sanitizer
Reason Discoloration and Presence of Foreign Substance
Class I · High risk Terminated
Heparin Sodium 10
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 5
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 5
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk Terminated
Heparin Sodium 2
Reason Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class II · Moderate risk Terminated
Heparin Sodium 5
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class I · High risk Terminated
Herbacil
Reason Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.
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 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.