Multi-event May 2015 FDA Recall Drug by Novartis Pharmaceuticals Corp.
This Multi-event Class III drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on May 22, 2015 for the product Drug. The FDA reported the reason for recall as failed stability specification. The product was distributed in NJ via 1 distributor and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1137-2015
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
05-22-2015
06-24-2015
19,658 packs
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ via 1 distributor
05-18-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 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.
Batch or Lot Expiration Information
Lot# : F8011, Exp May 2015
Recall Number: D-1138-2015
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
05-22-2015
06-24-2015
55,442 packs
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
NJ via 1 distributor
05-18-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : F0082, Exp May 2015
