Class II · Moderate risk Terminated
Dexpanthenol injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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Class II · Moderate risk Terminated
Calcium Gluconate injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
CoEnzyme-Q10 injectable
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class III · Low risk Terminated
Oxycodone and Acetaminophen Tablets
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 100 mL bags
Reason CGMP Deviations
Class II · Moderate risk Terminated
Thyroid Powder 25kg/drum
Reason CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
Class II · Moderate risk Terminated
Montelukast Sodium Tablets
Reason Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
Class II · Moderate risk Terminated
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet
Reason CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Class II · Moderate risk Terminated
Valsartan Tablets USP 320 mg
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk Terminated
Tyvaso Inhalation System Patient a) Starter Kit with TYVASO
Reason Defective Delivery System: Water ingress through the lower water cup sensor of the device.
Class II · Moderate risk Terminated
Megestrol Acetate Oral Suspension
Reason Supterpotent Drug
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class III · Low risk Terminated
Diltiazem HCl Extended-release Capsules
Reason Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class III · Low risk Terminated
Valsartan Tablets USP
Reason Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Class II · Moderate risk Terminated
Lisinopril Tablets USP
Reason Presence of Foreign Substance: Product complaint was received of metal contaminant observed in one tablet.
Class I · High risk Terminated
Living Well Remedies Weight Away Remedy
Reason Microbial Contamination of Non-Sterile Products: Weight Away Remedy is being recall due to out of specification microbial results.
Class II · Moderate risk Terminated
Valsartan 320 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 160 mg Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan 80 mg Tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.