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D-0678-2017 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — East Hanover, NJ

FDA drug recall D-0678-2017 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

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15

Reason for recall

Failed Impurities/Degradation Specifications.

Distribution pattern

nationwide

Code information

Lot #: 244661F, 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-0678-2017
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.

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