Home / Recalls / Novartis Pharmaceuticals Corp. / D-0679-2017

D-0679-2017 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

FDA drug recall D-0679-2017 was initiated by Novartis Pharmaceuticals Corp. on Mar 22, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications. The recall status is terminated (terminated Feb 5, 2020).

Recall details

Product Type: Drugs
Report Date: May 3, 2017
Initiation Date: Mar 22, 2017
Termination Date: Feb 5, 2020
Voluntary/Mandated: Voluntary: Firm initiated

Product description

Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution pattern

nationwide

Code information

Lot #: 244660F, Exp. FEB 2018

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0679-2017
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by Novartis Pharmaceuticals Corp.

D-1174-2023 Class I — SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL… (Sep 8, 2023)
D-1309-2019 Class I — Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by… (May 11, 2019)
D-0678-2017 Class III — Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15… (Mar 22, 2017)
D-1430-2015 Class III — Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules… (Jul 28, 2015)
D-1138-2015 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule… (May 22, 2015)
D-1137-2015 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule… (May 22, 2015)
D-1516-2014 Class III — Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only… (Jul 30, 2014)
D-1387-2014 Class III — Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule… (May 28, 2014)
D-1228-2014 Class III — Ritalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only… (Mar 3, 2014)
D-1227-2014 Class III — Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only… (Mar 3, 2014)