The Recall Desk
HighFDA (Drugs)·D-0059-2024·Announced 2023-10-25

Compounded Lidocaine-Phenylephrine Injectable Recalled Due to Sterility Assurance Issues

Pine Pharmaceuticals is recalling 9,673 vials of compounded lidocaine-phenylephrine injectable due to lack of assurance of sterility. Affected lots were distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall for lack of assurance of sterility on an injectable medication. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed contamination. Per the rubric, Class II with no reported illness and theoretical hazard scores at most 3 (High).

Plain-English summary

Pine Pharmaceuticals, LLC is recalling lidocaine-phenylephrine 1%-1.5% compounded injectable in 1 mL single-dose vials due to lack of assurance of sterility. The recalled product is a prescription-only medication manufactured at their facility in Tonawanda, New York.

The recall affects 9,673 vials distributed nationwide within the United States. Seven lots are involved, with expiration dates ranging from October 2023 through January 2024: Lot #67849 (exp. 10/25/2023), #67887 (exp. 10/28/2023), #68260 (exp. 11/14/2023), #68534 (exp. 11/27/2023), #68816 (exp. 12/12/2023), #69046 (exp. 12/20/2023), and #69971 (exp. 1/13/2024).

Healthcare providers and patients who have received this product should check the vial lot number and expiration date against the list above. Any vials from these lots should not be used. Patients and healthcare providers with questions or concerns should contact Pine Pharmaceuticals or consult with their healthcare provider.

The recalled product

Product
Lidocaine-phenylephrine 1%-1.5% 1mL Single Dose Vial, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Manufacturer
Pine Pharmaceuticals, LLC
Category
Drug — Compounded Injectable
Hazard
  • lack-of-sterility
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Lot #: 67849
  • Exp. Date 10/25/2023
  • 67887
  • Exp. Date 10/28/2023
  • 68260
  • Exp. Date 11/14/2023
  • 68534
  • Exp. Date 11/27/2023
  • 68816
  • Exp. Date 12/12/2023
  • 69046
  • Exp. Date 12/20/2023
  • 69971
  • Exp. Date 1/13/2024

Distribution

Distributed nationwide across the United States.

Related recalls

Same category