Class I - Dangerous
Lack of Assurance of Sterility: Malformed crimped collar seal
Sanofi-Aventis U.S.
Class I - Dangerous
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class I - Dangerous
Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.
Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Superpotent Drug: high out-of-specification result for magnesium.
Labeling: Incorrect or Missing Package Insert
Defective Delivery System; potential to have inaccurate dosage delivery
Defective Delivery System; potential to have inaccurate dosage delivery
Class I - Dangerous
Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil.
Class I - Dangerous
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
Class I - Dangerous
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.