Home / Recalls / Novartis Pharmaceuticals Corp. / D-1138-2015

D-1138-2015 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
June 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

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