D-1138-2015 Class III Terminated
FDA drug recall D-1138-2015 was initiated by Novartis Pharmaceuticals Corp. on May 22, 2015 and is designated Class III. Reason for recall: Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. The recall status is terminated (terminated May 18, 2016). Affected quantity: 55,442 packs.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 24, 2015
- Initiation Date
- May 22, 2015
- Termination Date
- May 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 55,442 packs
Product description
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 for recall
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Distribution pattern
NJ via 1 distributor
Code information
Lot#: F0082, Exp May 2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1138-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026