FDA Drug recall D-1138-2015
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack
- FDA Drug
- Class III
- terminated
- Published 2015-06-24
On 2015-06-24 the FDA classified a Class III recall of Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack by Novartis Pharmaceuticals, citing failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1138-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-05-22 |
| Published | 2015-06-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | NJ |
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.
Reason
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Identifiers
| code_info | Lot#: F0082, Exp May 2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1138-2015%22
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