Home / Recalls / Novartis Pharmaceuticals Corp. / D-1430-2015

D-1430-2015 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
September 23, 2015
Initiation Date
July 28, 2015
Termination Date
May 10, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,767 bottles

Product Description

Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540

Reason for Recall

Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.

Distribution Pattern

NJ - site for distributor

Code Information

Lot #: F0002, Exp 12/2016

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-1309-2019 Class I — Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Ha (May 11, 2019)
  • 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-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)