Compounded Ophthalmic Medication Bottles Mislabeled as Single-Use Syringes
Fagron Compounding Services is recalling 756 bottles of compounded ophthalmic medication because labels incorrectly identify the container as a 0.5mL single-use syringe instead of a 5mL dropper bottle. No adverse events have been reported.
What this means for you
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: FDA Class III recall for a labeling error with no reported illnesses or injuries. While the mislabel could potentially cause confusion regarding container type and size, the physical product is correct and no adverse events have been reported.
Plain-English summary
Fagron Compounding Services, located in Wichita, Kansas, has recalled 756 bottles of compounded ophthalmic medication containing Tropicamide 1%, Cyclopentolate 1%, Phenylephrine 2.5%, and Ketorolac 0.5%. The recall was initiated due to a labeling error: the dropper bottle labels incorrectly state the container is a 0.5mL single-use syringe rather than a 5mL dropper bottle.
The affected medication was distributed nationwide across the United States for hospital and office use. The recalled lot numbers are C274-000033372 (expiration date 01-17-2024) and C274-000033764 (expiration date 02-06-2024).
Healthcare providers and patients who have these bottles should discontinue use and contact Fagron Compounding Services or their healthcare provider. The label error could potentially cause confusion regarding the container size and administration method. No adverse events associated with this labeling error have been reported to date.
The recalled product
- Product
- Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For Topical Ophthalmic Use Only, Not for IV Use, This is a Compounded Drug, Hospital & Office Use Only, Fagron Sterile Services, 8710 E 34th St N Wichita, K
- Manufacturer
- Fagron Compounding Services
- Category
- Drug — Ophthalmic Medication
- Hazard
- mislabeling
- container-mismatch
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 (4)
- Lot #: C274-000033372
- Exp. Date 01-17-2024
- C274-000033764
- Exp. Date 02-06-2024
Distribution
Distributed nationwide across the United States.
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