SPOTLIGHT: FDA deems Medtronic warning a 'recall'

by admin |

Oh, by the way, that was a recall. The FDA tells Medtronic that its January warning to doctors--of the increased inflammation risk when its drug infusion systems SynchroMed and IsoMed were used with certain meds--would be classified as a Class I recall. The categorization doesn't change the warning or its recommendations. Report

Suggested Articles

Pfizer
Pharma

Pfizer wins FDA nod for Humira biosim, plans 2023 launch

Pfizer has scored FDA approval for its Humira biosimilar, but it can't launch the product for several years under a patent settlement.

by Eric Sagonowsky
Bristol-Myers Squibb
Pharma

Does BMS' party-line split FTC vote over Celgene spell trouble?

The 3-2 vote on the deal was split along the party lines, spelling trouble for future biopharma M&A deals should Democrats move into the White House.

by Angus Liu
Manufacturing

Recipharm bolsters inhalation business with deal for U.K. CDMO

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

by Eric Palmer