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Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Product contains cyclamates
Undeclared sulfites
Undeclared Red #3
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Presence of foreign tablets/capsules
Contains undeclared colors (FD&C Blue 1 and FD&C Red 40)
Elevated levels of MBC (carbendazim) thiophanate-methyl.
Product contains cyclamates.
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Undeclared Red #3, Blue #1, Potassium Sorbate, and Propylene Glycol.
Undeclared Red #40 and Potassium Sorbate.
Undeclared Red #40 and Potassium Sorbate
Superpotent; sodium benzoate preservative
Product is likely Canola Oil, not Extra Virgin Olive Oil
Underprocessing
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
LABELING: LABEL MIX-UP