Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Eyewash Purified water 98.3%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Emergency First Aid Eyewash
Reason CGMP Deviations
Class II · Moderate risk Terminated
Valsartan/HCTZ 320mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160 mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Omega-3-Acid Ethyl Esters Capsules USP
Reason API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk Terminated
Fluconazole Injection
Reason Failed Stability Specifications: lot out of specification for elevated water vapor.
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class III · Low risk Terminated
Diazepam Rectal Gel
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
alba BOTANICA sport mineral sunscreen
Reason Incorrect Product Formulation: wrong sunscreen product in the package.
Class II · Moderate risk Terminated
Fluocinolone Acetonide Topical Solution
Reason Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets
Reason Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class II · Moderate risk Terminated
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL
Reason CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Class II · Moderate risk Terminated
Monsel's Solution
Reason CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Class I · High risk Terminated
Piperacillin and Tazobactam for Injection USP 3.375 grams per vial
Reason Presence of Particulate Matter: identified as glass and silicone material
Class II · Moderate risk Terminated
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Reason Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class I · High risk Terminated
Neostigmine Methylsulfate Injection Solution
Reason Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class I · High risk Terminated
Neostigmine Methylsulfate Injection Solution
Reason Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as Neostigmine Methylsulfate 1 mg per mL, 3 mg per 3 mL.
Class II · Moderate risk Terminated
Daptomycin for Injection
Reason Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk Terminated
Nitrofurantoin Oral Suspension USP
Reason Subpotent Drug and Failed Content Uniformity.
Class III · Low risk Terminated
Enalapril Maleate
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.