Status
Terminated
Drug Enforcement D-0058-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
October 25, 2023
Termination Date
May 15, 2024
Product Information
- Product description
- Moxifloxacin in Balanced Salt Solution 400 mcg/0.4 mL (100 mcg/0.1 mL) 1 mL syringes, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Product quantity
- 2176 syringes
- 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-0058-2024
- Event ID
- 93154
- Recall initiation date
- October 2, 2023
- Center classification date
- October 19, 2023
- Code info
- Lot #: 67623, Exp. Date 10/15/2023; 67919, Exp. Date 10/29/2023; 68917, Exp. Date 12/16/2023; 69079, Exp. Date 12/23/2023; 69120, Exp. Date 12/24/2023
- More code info
- —