Bausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Defect
Bausch & Lomb is recalling Tropicamide Ophthalmic Solution 0.5% 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect rather than a physical hazard.
Plain-English summary
Bausch & Lomb, Inc. is recalling Tropicamide Ophthalmic Solution USP, 0.5%, packaged in 15 mL bottles. The recall involves 119,393 bottles distributed nationwide in the U.S. and Puerto Rico. The specific lots affected include 199001, 222591, 224491, 229241, 232941, 239921, 241701, and 246851, with expiration dates ranging from January 2016 to July 2017.
The reason for the recall is a labeling issue where the package insert is missing updates compared with the reference drug insert. This is classified as an FDA Class III recall, indicating that the product is not likely to cause adverse health consequences or death.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or Bausch & Lomb, Inc. for credit or replacement.
The recalled product
- Product
- TROPICAMIDE (TROPICAMIDE)
- Brand
- TROPICAMIDE
- Manufacturer
- Bausch & Lomb, Inc.
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 119,393
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 (16)
- Lot #:199001
- Expiry: 01/2016
- Lot #: 222591
- Expiry: 04/2016
- Lot #: 224491
- Expiry: 06/2016
- Lot #: 229241
- Expiry: 08/2016
- Lot #: 232941
- Expiry: 11/2016
- Lot #: 239921
- Expiry: 02/2017
- Lot #: 241701
- Expiry: 04/2017
- Lot #: 246851
- Expiry: 07/2017.
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.
See all 3 products in this recall →Related recalls
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- LowBausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Error
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