Why it was recalled
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
Product description
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, KS 67226. NDC 71266-8240-01
Lot numbers, UPCs & expiration codes
Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0125-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 10, 2023
- FDA report date
- Dec 6, 2023
- Quantity
- 756 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fagron Compounding Services
Original FDA data
Every field from FDA enforcement report D-0125-2024, exactly as published.
Show all FDA fields
- City
- Wichita
- State
- KS
- Status
- Ongoing
- Country
- United States
- Event ID
- 93453
- Address
- 8710 E 34th St N
- Code information
- Lot #: C274-000033372, Exp. Date 01-17-2024; C274-000033764, Exp. Date 02-06-2024
- Postal code
- 67226-2636
- Report date
- Dec 6, 2023
- Product type
- Drugs
- Recall number
- D-0125-2024
- Classification
- Class III
- Recalling firm
- Fagron Compounding Services
- Product quantity
- 756 bottles
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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, KS 67226. NDC 71266-8240-01
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 10, 2023
- Initial firm notification
- Telephone
- Center classification date
- Nov 28, 2023