Drug product
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.
D-1138-2015
Product summary
- Event
- Event 71310
- Status
- Terminated
- Classification
- Class III
- Quantity
- 55,442 packs
- Official record key
drug-enforcement:D-1138-2015
Official wording
Reason: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Code information: Lot#: F0082, Exp May 2015
Distribution pattern: NJ via 1 distributor
Derived failure modes
-
Potency or specification failure
out of specification