14 recalls · Class III, newest first
Reason Superpotent drug: Assay results were slightly above specification at the time zero point.
Reason Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Reason Sub-potent Drug: Lower potency than labeled.
Reason Labeling: Wrong Barcode- One (1) of every forty (40) unit dose blister will contain incorrect barcode information that causes a 125mcg unit dose is…
Reason Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet…
Reason Subpotent: Out of Specification for Assay Test at the 3-month time point.
Reason Failed Impurities/Degradation Specifications
Reason Failed Stability Specifications
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Reason Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each…
Reason Labeling; Incorrect NDC number on outer carton of product.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is…
Reason Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the…
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.