FDA recall D-1514-2022

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 Parkway, Tonawanda, NY 14150.

Reason for recall

Lack of Assurance of Sterility

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-07-27

Report date

2022-09-21

Termination date

2022-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tonawanda, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1514-2022