Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Spectrum Laboratory Products
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Class I - Dangerous
CGMP Deviations: Presence of NDMA impurity detected in product.
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Class I - Dangerous
CGMP Deviations: Received notice from supplier that there is potential glass contamination.
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
CGMP Deviations: these repackaged and redistributed products are being recalled due to a recall notice from the active pharmaceutical ingredient manufacturer for deviations from current Good Manufacturing Practices that were found during a recent FDA inspection.
Class I - Dangerous
Does not meet monograph: product exhibits lead levels in excess of the USP monograph limits.
Class I - Dangerous
CGMP Deviations; Stored/dispensed in a non-GMP compliant warehouse at S.I.M.S., Italy.