Novartis Recalls Pilocarpine Hydrochloride Ophthalmic Solution for Impurity Failures
Novartis Pharmaceuticals Corp. is recalling Pilocarpine Hydrochloride Ophthalmic Solution 4% 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric indicates is typically a score of 1 or 2. The hazard involves failed impurities/degradation specifications without reported illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling Pilocarpine Hydrochloride Ophthalmic Solution 4%, packaged in 15 mL bottles. The product is a prescription-only ophthalmic solution manufactured by Alcon Laboratories, Inc. in Fort Worth, Texas, and distributed by Sandoz in Princeton, New Jersey. The specific lot number is 244660F, with an expiration date of February 2018.
The recall was initiated because the product failed impurities and degradation specifications. This indicates that the chemical composition of the drug did not meet the required quality standards for safety and purity.
The recall is distributed nationwide. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- PILOCARPINE HYDROCHLORIDE (PILOCARPINE HYDROCHLORIDE)
- Brand
- PILOCARPINE HYDROCHLORIDE
- 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 #: 244660F
- 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.
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