FDAClass IIIMay 3, 2017

Pilocarpine Hydrochloride Ophthalmic Solution 4% recall: Impurity Out of Spec

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

Why was Pilocarpine Hydrochloride Ophthalmic Solution 4% 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 #: 244660F, Exp. FEB 2018

Product
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
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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