Tecfidera (dimethyl fumarate) delayed-release capsules, 240 mg, 60-count bottle, Rx only, Manufactured by: Biogen Inc…
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
9 FDA recalls mention Dimethyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Dimethyl.
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic…
Reason Marketed without an approved NDA/ANDA - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility…
Reason CGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
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