Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials…
Reason Lack of Assurance of Sterility: environmental monitoring failure.
9 FDA recalls mention Formoterol. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Formoterol.
Reason Lack of Assurance of Sterility: environmental monitoring failure.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of Processing Controls
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
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 Failed Stability Specification; out of specification result for particle size distribution during stability testing
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