Status
Terminated
Drug Enforcement D-0063-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
October 25, 2023
Termination Date
May 15, 2024
Product Information
- 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.
- Product quantity
- 662 dropper
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Pine Pharmaceuticals, LLC
- Address
-
355 Riverwalk Pkwy, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0063-2024
- Event ID
- 93154
- Recall initiation date
- October 2, 2023
- Center classification date
- October 19, 2023
- Code info
- Lot #: 67659, Exp. Date 10/16/2023; 70316, Exp. Date 1/30/2024
- More code info
- —