Fagron Compounding Services 2023-12-06 Health moderate FDA
Health · FDA · Recall #FDA-D-0125-2024
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL),… Recall
Issued December 6, 2023 · Fagron Compounding Services
In December 2023, Fagron Compounding Services recalled the Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL),…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
What you should do
- 1 Stop using Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL),… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fagron Compounding Services to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fagron Compounding Services
- Category
- Health
- Recall date
- December 6, 2023
- Units affected
- Not reported
- Sold at
- Nationwide in the USA
- Recall number
- FDA-D-0125-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Fagron Compounding Services has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.