D-0064-2024 Class II Terminated

Recalled by Pine Pharmaceuticals, LLC — Tonawanda, NY

FDA drug recall D-0064-2024 was initiated by Pine Pharmaceuticals, LLC on October 2, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated May 15, 2024). Affected quantity: 860 syringes.

Recall Details

Product Type
Drugs
Report Date
October 25, 2023
Initiation Date
October 2, 2023
Termination Date
May 15, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
860 syringes

Product Description

Lidocaine HCL 2% and Oxymetazoline HCl 0.025% Solution for intranasal administration, 2 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 67808, Exp. Date 10/23/2023