FDA announced the “recall”, or market withdrawal, of certain lots of PRADAXA (DABIGATRAN EXTILATE) during August 2011. At the time, FDA classified the information as follows: “RECALLS AND FIELD CORRECTIONS: DRUGS – CLASS II“. The reason communicated for this action was :”Wrong Bar Code; Incorrect bar code read on a Pradaxa 75 mg blister unit dose. When scanned, the blister bar code identified the NDC as Pradaxa 150 mg NDC“.
This “recall” affected 1,143 boxes/10 blister units/6/75 mg capsules. How well publicized this market withdrawal was at the time remains under investigation by the sponsor of this site. Whether any of the recalled PRADAXA was available to the public also remains an open question for this author.
Gabriel F. Zambrano, P.A., is the sponsor of PRADAXA CASES. Gabriel F. Zambrano, P.A., is actively investigating PRADAXA CASES involving serious personal injuries, or death, from use of PRADAXA (DABIGATRAN EXTILATE).