FDAClass IIIMay 3, 2017

Isopto Carpine recall: Impurity Out of Spec

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

Why was Isopto Carpine recalled?

Failed Impurities/Degradation Specifications.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 244661F, Exp. Feb 2018

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
Recalling firm
Novartis Pharmaceuticals Corp.
Quantity
N/A
Distribution
nationwide
Recall date
May 3, 2017
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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