Class II · Moderate risk Ongoing
Chantix
Reason CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Xolair
Reason Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Class II · Moderate risk Terminated
QiYu Hand Sanitizer Gel
Reason Subpotent
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class II · Moderate risk Terminated
Native Fluoride Toothpaste for Sensitive Teeth
Reason Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluoride-Free instead of With Fluoride
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED Hand Sanitizer Gel
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Ongoing
MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera
Reason CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class II · Moderate risk Terminated
Advance Hand Sanitizer
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Terminated
ProtectoRx
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Terminated
DiBAR LABS Hand Sanitizer
Reason CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
Class II · Moderate risk Ongoing
Imperia Elita Vitaccino Coffee
Reason Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Class II · Moderate risk Completed
BusPIRone Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
Micardis Tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
Metformin HCl Extended-Release Tablets
Reason Presence of foreign substance: identified as activated carbon.
Class II · Moderate risk Terminated
Sterile Water for Inj.
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP 100 mg/5mL
Reason Subpotent Drug
Class II · Moderate risk Terminated
Sodium Chloride 0.9%
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk Ongoing
Preferred Pharmaceuticals Inc.
Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
Class II · Moderate risk Terminated
Haloperidol Decanoate Injection
Reason Lack of Assurance of Sterility