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
Recalled September 21, 2022 · FDA recall D-1514-2022 · Pine Pharmaceuticals
Hazard
Lack of Assurance of Sterility · FDA Class II
Units
a) 920 syringes; b) 3263 syringes
Sold at
Product was distributed to direct accounts in AL, CA, NC and NY
Description
Lack of Assurance of Sterility
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.
Manufacturer(s)
Pine Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →