FDA-Drug2022-09-21Class II
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.
Pine Pharmaceuticals, LLC
Hazard
Lack of Assurance of Sterility
Sold states
Product was distributed to direct accounts in AL, CA, NC and NY
Affected count
a) 920 syringes; b) 3263 syringes
Manufactured in
355 Riverwalk Pkwy, Tonawanda, NY, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1514-2022Don't want to check this manually?
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