Multi-event March 2017 FDA Recall Pilocarpine Hydrochloride by Novartis Pharmaceuticals Corp.
This Multi-event Class III drug recall was voluntarily initiated by Novartis Pharmaceuticals Corp. on March 22, 2017 for the product Pilocarpine Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specifications.. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0678-2017
Failed Impurities/Degradation Specifications.
03-22-2017
05-03-2017
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
nationwide
02-05-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 244661F, Exp. Feb 2018
Recall Number: D-0679-2017
Failed Impurities/Degradation Specifications.
03-22-2017
05-03-2017
N/A
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Novartis Pharmaceuticals Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
nationwide
02-05-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 244660F, Exp. FEB 2018
