FDA Drug recall D-0053-2024
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawa…
- FDA Drug
- Class II
- terminated
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawa… by Pine Pharmaceuticals, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0053-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-10-02 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pine Pharmaceuticals |
| Distribution | US |
Product
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Reason
Lack of Assurance of Sterility
Identifiers
| code_info | Lot #: 69802, Exp. Date 02/28/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0053-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.