Categories
Resources
Your Recalls
Loading...
Get email alerts when new recalls match your interests.
Discoloration
Lack of Assurance of Sterility
Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
LABELING: LABEL MIX-UP.
Defective Delivery System: incorrect silicone oil-free NormJect 10 mL Luer Lock Solo syringes packaged in the pack, instead of the required silicone oil-free NormJect 10 mL Luer Solo syringes (luer slip connection).
Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Products may contain undeclared sesame
Superpotent Drug
Failed Impurities/Degradation Specifications - at 18-month Stability testing
Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.