The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0678-2017·Announced 2017-05-03

Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Novartis Pharmaceuticals Corp. is recalling Isopto Carpine (pilocarpine hydrochloride ophthalmic solution) 4%, packaged in 15 mL bottles. The recall involves Lot #244661F with an expiration date of February 2018. The product is a prescription-only medication manufactured by Alcon Laboratories, Inc.

The recall was initiated because the product failed impurities and degradation specifications. This indicates that the chemical composition of the eye drops did not meet the required quality standards for purity and stability.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. The recall is classified as Class III by the FDA, which typically indicates that the product is unlikely to cause adverse health consequences.

The recalled product

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
Manufacturer
Novartis Pharmaceuticals Corp.
Category
Drug — Ophthalmic Solution
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: 244661F
  • Exp. Feb 2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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