Pilocarpine Hydrochloride Solution/ Drops
FDA Recall NDC 61314-203
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pilocarpine Hydrochloride (NDC 61314-203). A significant event, classified as Class III, was initiated on Mar 22, 2017 by Sandoz Inc. The reported reason for this action was: "Failed Impurities/Degradation Specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
March 2017 Class III Recall: Failed Impurities/Degradation Specifications.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications.
Mar 22, 2017
May 03, 2017
N/A
Recall Profile & Regulatory Data
Event ID
76756
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Novartis Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Feb 05, 2020
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
Batch or Lot Expiration Information
Lot# : 244660F, Exp. FEB 2018
Affected Packages Involved in this Recall
61314-203-15Product
61314-204-15Product
61314-206-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
