170 recalls · Class III, newest first
Chemical contamination: Firm's inspection discovered the presence of 2-phenylphenol in the product due to migration from the cardboard cartons in which the product is packaged.
Failed Dissolution Specification: This product recall is due to the product lot # 50077231 exceeding dissolution specifications. All other test specifications were met.
Chemical Contamination: The recall has been initiated based on multiple complaints received from pharmacists and consumers reporting that they detected an off-odor, described as moldy, musty or fishy in nature which has been identified as trace levels of Tribromoanisole (TBA) and Trichloroanisole (TCA).
Failed Stability Specifications; out of specification results at the 9 month stability time point for color, dissolution and related compounds.
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Labeling: Missing label
Discoloration; Product may not meet specifications for color description once reconstituted.
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.
Cross Contamination with Other Products: Product was mixed with another type of mouth wash.
Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Subpotent Drug
Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.