10 FDA recalls mention Dabigatran. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dabigatran.
Reason Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
Reason Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
Reason Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Reason Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II…
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Reason CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Reason Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
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