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Product labeling is incorrect.
Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
Failed Impurities/Degradation Specifications: OOS for unknown impurities.
Recalling Caffeine-Free Barq s Root Beer 12 Pack due to mislabeling.
Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Product contains undeclared soy lecithin.
Incorrect ingredients listed: Does not include Amaranth flour nor baking soda, but does include baking powder and vanilla
Lack of Assurance of Sterility
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Product contains undeclared ingredients, Hydroxypropyl Methylcellulose (HPMC), Titanium Dioxide, Polyethylene Glycol (PEG).
Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Product is mislabeled. Some pint containers of Caramel Cone Crunch ice cream may have been packaged incorrectly with a "Crumbs Along the Mohawk" lid.
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.