Home / Recalls / Novartis Pharmaceuticals Corp. / D-1174-2023

D-1174-2023 Class I Ongoing

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

Recall Details

Product Type
Drugs
Report Date
September 27, 2023
Initiation Date
September 8, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1272 bottles

Product Description

SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, NDC 0078-0110-22.

Reason for Recall

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.

Distribution Pattern

Nationwide in the USA

Code Information

FX001691, Exp. 12/31/2025

Other recalls by Novartis Pharmaceuticals Corp.

  • 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-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)