Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Distributed: NationwideReason: First Aid Only, Inc is recalling Smart Tab First Aid ezRefill System Ibuprofen boxes and First Aid Cabinets containing these Ibuprofen boxes. Ibuprofen boxes (FAE 7014) were accidentally used to package aspirin packs (10 packs of 2 / 235mg tablets).
Distributed: NationwideReason: Marketed Without an Approved NDA/ANDA; Product contains undeclared diclofenac and methocarbamol.
Distributed: Nationwide including Puerto RicoReason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used for parenteral injection.
Distributed: NationwideReason: Marketed Without An Approved NDA/ANDA: Parenteral product is sold over the counter whose labeling indicates it is to be used for the treatment of disease.
Distributed: NationwideReason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling indicates it is to be used parenterally for drug claims.
Distributed: NationwideReason: Marketed Without An Approved NDA/ANDA: Parenteral product is labeled for use as an antidote.
Distributed: NationwideReason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Distributed: NationwideReason: Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Distributed: NationwideReason: Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Distributed: USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.