LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315
KRS Global Biotechnology
Lack of Assurance of Sterility
💊 Drugs • 12,141 recalls
KRS Global Biotechnology
Lack of Assurance of Sterility
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.
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
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:
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.
Preferred Pharmaceuticals
Failed Impurities/Degradation Specifications
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.
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Shire Human Genetic Therapies
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
West-Ward Columbus
Failed Impurities/Degradation Specificattion
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications