Class III · Low risk Terminated
Erythromycin Topical Solution USP
Reason Failed Impurities/Degradation Specifications
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Class I · High risk Terminated
Prairie Wolf Distillery Alcohol Antiseptic 80%
Reason Hand sanitizer packaged in bottles that resemble beverage containers.
Class I · High risk Terminated
Topotecan Injection 4 mg/4mL
Reason Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Class III · Low risk Terminated
B-Force
Reason Superpotent
Class II · Moderate risk Terminated
Acetaminophen 325 mg tablets
Reason cGMP deviations: Discolored acetaminophen
Class II · Moderate risk Terminated
Solifenacin Succinate Tablets
Reason CGMP Deviations
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 III · Low risk Terminated
Phytonadione Tablets 5 mg
Reason Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Class III · Low risk Terminated
Ketamine HCl Injection Solution
Reason Labeling: Incorrect Exp. Date: Incorrect BUD.
Class III · Low risk Terminated
Phytonadione Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Mephyton
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
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 III · Low risk Terminated
Levetiracetam Tablets USP
Reason Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Product is labeled correctly as Levetiracetam
Class II · Moderate risk Terminated
DermOtic Oil
Reason Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Class I · High risk Terminated
maXXzen Platinum 12000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Platinum 8000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class I · High risk Terminated
PremierZEN Gold 7000 capsule
Reason Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Class II · Moderate risk Terminated
Diflorasone Diacetate Ointment USP
Reason Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Class III · Low risk Terminated
Readyprep Chg
Reason Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.
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 III · Low risk Terminated
Sirolimus Tablets 1 mg
Reason Failed Impurities/Degradation Specifications
Class I · High risk Terminated
C-Progesterone Oil 100 Mg/Ml
Reason Non-Sterility
Class I · High risk Terminated
Poseidon Platinum 3500 capsule
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.