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 9.82 parts per million.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02
Shire Human Genetic Therapies
Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02
Shire Human Genetic Therapies
Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Failed Dissolution Specifications:
Class I - Dangerous
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Preferred Pharmaceuticals
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class I - Dangerous
cGMP Deviations: Potential glass contamination
Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
Shire Human Genetic Therapies
Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Shire Human Genetic Therapies
Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I - Dangerous
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class I - Dangerous
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
West-Ward Columbus
Class I - Dangerous
Failed Impurities/Degradation Specificattion
Class I - Dangerous
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Class I - Dangerous
Failed Impurities/Degradation Specifications
Class I - Dangerous
Failed Impurities/Degradation Specifications