Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Dr. Reddy's Laboratories
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Dr. Reddy's Laboratories
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class I - Dangerous
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
Dr. Reddy's Laboratories
Class I - Dangerous
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
C & A Naturistics
Class I - Dangerous
Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Class I - Dangerous
CGMP Deviations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58
Fresenius Kabi Compounding
Class I - Dangerous
CGMP violations
Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
Fresenius Kabi Compounding
Class I - Dangerous
cGMP violations
First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.4 g) per tube, Distributed by: Rugby Laboratories, Indianapolis, IN 46268. Made in China. NDC: 0536-1271-80
Zhejiang Jingwei Pharmaceutical Co.
Class I - Dangerous
Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
Class I - Dangerous
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.