Bausch & Lomb Recalls Cyclopentolate Hydrochloride Ophthalmic Solution for Labeling Errors
Bausch & Lomb is recalling Cyclopentolate Hydrochloride Ophthalmic Solution 1% because the package insert is missing updates compared to the reference drug insert.
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 by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding missing updates in the package insert.
Plain-English summary
Bausch & Lomb, Inc. is recalling Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, packaged in 2 mL and 15 mL bottles. The recall is due to a labeling issue where the package insert is missing updates compared with the reference drug insert.
The affected product is a prescription-only ophthalmic solution distributed nationwide in the United States, including Puerto Rico. The recall covers specific lots of the 2 mL and 15 mL bottles, with quantities totaling over one million units.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product is found, it should be returned to the distributor or manufacturer for credit or replacement.
The recalled product
- Product
- CYCLOPENTOLATE HYDROCHLORIDE (CYCLOPENTOLATE HYDROCHLORIDE)
- Brand
- CYCLOPENTOLATE HYDROCHLORIDE
- Manufacturer
- Bausch & Lomb, Inc.
- 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 (20)
- a) Lot #: 199691
- Expiry: 02/2016
- Lot # 221481
- Expiry: 03/2016
- Lot #: 223921
- Expiry: 05/2016
- Lot #: 226211
- Expiry: 06/2016
- Lot #: 228611
- Expiry: 08/2016
- Lot #: 230711
- Expiry: 09/2016
- Lot #: 232591
- Expiry: 11/2016
- Lot #: 234551
- Expiry: 12/2016
- Lot #: 238871
- Expiry: 01/2017
- Lot #: 239801
- Expiry: 02/2017
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bausch & Lomb, Inc. 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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