Agency classClass IIOur severity:High FDA (Drugs)·D-1514-2022·Announced 2022-09-21

Injectable Anesthetic Solution Recalled for Lack of Sterility Assurance

Pine Pharmaceuticals is recalling Bupivacaine and Lidocaine injectable solutions for eye anesthesia due to lack of assurance of sterility. The product was distributed to direct accounts in four states.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II recall of an injectable pharmaceutical lacking sterility assurance. While no adverse events are reported in the source, the potential for contamination in an injectable product poses significant risk of harm.

Plain-English summary

Pine Pharmaceuticals, LLC is recalling Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection (Rx only) due to lack of assurance of sterility. The affected product is distributed in two prefilled syringe sizes: 10 mL (Item# 803, barcode 6919408031) and 5 mL (Item# 933, barcode 6919409331). A total of 4,183 syringes were distributed to direct accounts.

Distribution was limited to Alabama, California, North Carolina, and New York. The affected lot numbers are 58366, 60247, 54825, 57583, 59343, and 60355, with expiration dates ranging from August 2022 to December 2022.

This is a prescription-only injectable anesthetic used for eye procedures. The FDA has classified this as a Class II recall. Individuals who have used or have access to affected lots should consult with their healthcare provider.

The recalled product

Product: Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10 mL prefilled syringe, Item# 803, barcode 6919408031; b) 5 mL prefilled syringe, Item# 933, barcode 6919409331, Rx only, Pine Pharmaceuticals, 355 Riverwalk…
Manufacturer: Pine Pharmaceuticals, LLC
Category: Drug — Ophthalmic Injectable
Hazard: sterility-failure
contamination-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 (12)

Lot #s: a) 58366
exp. date 09/26/2022
60247
exp. date 12/04/2022
b) 54825
exp. date 08/10/2022
57583
exp. date 08/22/2022
59343
exp. date 10/30/2022
60355
exp. date 10/11/2022

Distribution

Distributed in 4 states:

Same manufacturer · Pine Pharmaceuticals, LLC

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Same hazard · sterility failure