Class I - Dangerous
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
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Prescription Drugs
💊 Drugs • 11,927 recalls
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Class I - Dangerous
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
Class I - Dangerous
Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications
Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534; NDC 68382-092-05
Zydus Pharmaceuticals USA
Class I - Dangerous
Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Class I - Dangerous
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
Dr. Reddy's Laboratories
Class I - Dangerous
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Volumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Iso-Tex Diagnostics
Class I - Dangerous
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
Class I - Dangerous
Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class I - Dangerous
Subpotent Product: assay results for Amoxicillin were below the specification limits.
HCG 23 Day Injection Extra Strength, vials, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN 1-800-263-8890
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.
Prostaglandin Tri-Mix 2.5:7.5:0.25 Injection, 2 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Anderson Compounding Pharmacy, Inc.
Class I - Dangerous
Lack of sterility assurance.