Class II · Moderate risk
Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Foradil Aerolizer
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.
Drug: Formoterol
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1138-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Formoterol recalls
See all
Class II · Moderate risk
Bevespi Aerosphere
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Formoterol 12mcg / Budesonide 0.5mg
Lack of Processing Controls
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class II · Moderate risk
Formoterol Fumarate Dihydrate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Novartis Pharmaceuticals Corp.
All 2015 recalls
Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
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