Home / Recalls / Novartis Pharmaceuticals Corp. / D-1309-2019

D-1309-2019 Class I Terminated

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

Recall Details

Product Type
Drugs
Report Date
May 29, 2019
Initiation Date
May 11, 2019
Termination Date
November 28, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
792 cartons

Product Description

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.

Reason for Recall

Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

Distribution Pattern

Nationwide with in the United States

Code Information

Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.

Other recalls by Novartis Pharmaceuticals Corp.

  • D-1174-2023 Class I — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bott (September 8, 2023)
  • D-0678-2017 Class III — Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 (March 22, 2017)
  • D-0679-2017 Class III — Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx (March 22, 2017)
  • D-1430-2015 Class III — Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. (July 28, 2015)
  • D-1138-2015 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 6 (May 22, 2015)
  • D-1137-2015 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 1 (May 22, 2015)
  • D-1516-2014 Class III — Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manu (July 30, 2014)
  • D-1387-2014 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 6 (May 28, 2014)
  • D-1227-2014 Class III — Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, M (March 3, 2014)
  • D-1228-2014 Class III — Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, M (March 3, 2014)