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Class III: unlikely to cause harmTerminated

Novartis Pharmaceuticals Isopto Carpine Recall

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bot…

Novartis Pharmaceuticals Corp. · East Hanover, NJ

Risk level
Class III
Reported by FDA
May 3, 2017
Recall ID
D-0678-2017
Check your lot numberHow we source this data

Summary

Novartis Pharmaceuticals recalled Isopto Carpine starting Mar 22, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0678-2017 on May 3, 2017. Reason: Failed Impurities/Degradation Specifications. Status: Terminated.

Why it was recalled

Failed Impurities/Degradation Specifications.

Product description

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

Lot numbers, UPCs & expiration codes

Lot #: 244661F, Exp. Feb 2018

Where it was sold

nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0678-2017
Classification
Class III
Status
Terminated
Recall initiated
Mar 22, 2017
FDA report date
May 3, 2017
Quantity
N/A
Recall type
Voluntary: Firm initiated
Recalling firm
Novartis Pharmaceuticals Corp.

Original FDA data

Every field from FDA enforcement report D-0678-2017, exactly as published.

Show all FDA fields
City
East Hanover
State
NJ
Status
Terminated
Country
United States
Event ID
76756
Address
1 Health Plz
Code information
Lot #: 244661F, Exp. Feb 2018
Postal code
07936-1016
Report date
May 3, 2017
Product type
Drugs
Recall number
D-0678-2017
Classification
Class III
Recalling firm
Novartis Pharmaceuticals Corp.
Termination date
Feb 5, 2020
Reason for recall
Failed Impurities/Degradation Specifications.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
nationwide
Recall initiation date
Mar 22, 2017
Initial firm notification
Letter
Center classification date
Apr 21, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0678-2017, published May 3, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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