Recalls / Class III

Class IIID-0678-2017

Product

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

Affected lot / code info

Lot #: 244661F, Exp. Feb 2018

Why it was recalled

Failed Impurities/Degradation Specifications.

Recalling firm

Firm

Novartis Pharmaceuticals Corp.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1 Health Plz, N/A, East Hanover, New Jersey 07936-1016

Distribution

Quantity

N/A

Distribution pattern

nationwide

Timeline

Recall initiated

2017-03-22

FDA classified

2017-04-21

Posted by FDA

2017-05-03

Terminated

2020-02-05

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0678-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.