Bausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Error
Bausch & Lomb is recalling Tropicamide Ophthalmic Solution because the package insert is missing updates compared to the reference drug insert.
What this means for you
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 indicates the product is not likely 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 Tropicamide 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 U.S., including Puerto Rico. The recall covers specific lots of both 2 mL and 15 mL bottles, with quantities totaling over 1 million units.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatments if necessary.
The recalled product
- Product
- TROPICAMIDE (TROPICAMIDE)
- Brand
- TROPICAMIDE
- 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 #: 232601
- Expiry: 01/2016
- Lot #: 233471
- Expiry: 02/2016
- Lot #: 234901
- Expiry: 03/2016
- Lot #: 238861
- Expiry: 04/2016
- Lot #: 239781
- Lot #: 243351
- Expiry: 08/2016
- Lot #: 244931
- Expiry: 09/2016. b) Lot #: 198821
- Lot #: 198901
- Lot #: 199961
- Lot #: 220111
- Lot #: 222281
- Lot #: 222291
- Lot #: 224841
- Expiry: 06/2016
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.
See all 3 products in this recall →Related recalls
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- LowBausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Defect
FDA (Drugs) · 2016-02-03
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