Bupivacaine HCl 0 recalled over sterility concerns

Recall date

July 27, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pine Pharmaceuticals, LLC recalls Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar or Peribulbar Injection; packaged in a) 10…

Recall number

D-1514-2022

FDA classification

Class II

Brand / firm

Pine Pharmaceuticals, LLC

Sold / distributed

Product was distributed to direct accounts in AL, CA, NC and NY

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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 Parkway, Tonawanda, NY 14150.