Abler FDA Warning Letter

October 2014 the FDA issued a “warning letter” to Abler stating they are not in compliance with the law.

Also, very interesting is this quote:

In addition, testing by FDA of samples of the drug AbGard revealed that the amount of active ingredient (omeprazole) in the drug did not correspond with the amount represented on the labeling. Specifically, the drug was found to be super-potent at 111.3% of the label claim for potency. The drug is therefore adulterated under section 501 © of the FD&C Act [21 U.S.C. § 351©], in that its strength differs from that which it purports or is represented to possess"

We all know it’s effective…better stock up now! :slight_smile:
http://www.fda.gov/iceci/enforcementactions/warningletters/2014/ucm422545.htm

Multiple threads on this with a plethora of discussion back in 2014 when the letters were issued. A search will turn it all up.