Pine Pharmaceuticals Endophth Kit Vancomycin Recall: FDA Class II

Why it was recalled

Lack of Assurance of Sterility

Product description

Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Lot numbers, UPCs & expiration codes

Lot #: 69986, Exp. Date 11/15/2023

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-0052-2024
Classification: Class II
Status: Terminated
Recall initiated: Oct 2, 2023
FDA report date: Oct 25, 2023
Quantity: 201 kits
Recall type: Voluntary: Firm initiated
Recalling firm: Pine Pharmaceuticals, LLC

Original FDA data

Every field from FDA enforcement report D-0052-2024, 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 #: 69986, Exp. Date 11/15/2023
Postal code: 14150-5837
Report date: Oct 25, 2023
Product type: Drugs
Recall number: D-0052-2024
Classification: Class II
Recalling firm: Pine Pharmaceuticals, LLC
Product quantity: 201 kits
Termination date: May 15, 2024
Reason for recall: Lack of Assurance of Sterility
Voluntary / mandated: Voluntary: Firm initiated
Product description: Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), 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

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0052-2024, published Oct 25, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Pine Pharmaceuticals Endophth Kit Recall

Summary