Why it was recalled
Lack of Assurance of Sterility
Product description
Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Lot numbers, UPCs & expiration codes
Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024
Where it was sold
Nationwide within the United States
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-0063-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 662 dropper
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pine Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0063-2024, exactly as published.
Show all FDA fields
- City
- Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 93154
- Address
- 355 Riverwalk Pkwy
- Code information
- Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024
- Postal code
- 14150-5837
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0063-2024
- Classification
- Class II
- Recalling firm
- Pine Pharmaceuticals, LLC
- Product quantity
- 662 dropper
- Termination date
- May 15, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Tropi-Phen (tropicamide 1%, phenylephrine 2.5%) ophthalmic solution, 5mL multi-use dropper, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2023