PlainRecalls
FDA Drug Moderate Class II Terminated

Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Reported: October 25, 2023 Initiated: October 2, 2023 #D-0053-2024

Product Description

Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
Pine Pharmaceuticals, LLC
Units Affected
128 bags
Distribution
Nationwide within the United States
Location
Tonawanda, NY

Frequently Asked Questions

What product was recalled?
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.. Recalled by Pine Pharmaceuticals, LLC. Units affected: 128 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on October 25, 2023. Severity: Moderate. Recall number: D-0053-2024.