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Recall D-1514-2022

Description: 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.

Recall D-1514-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1514-2022
Event ID90854
DistributionProduct was distributed to direct accounts in AL, CA, NC and NY
Quantitya) 920 syringes; b) 3263 syringes
Recall ReasonLack of Assurance of Sterility
Drug ClassificationClass II
Drug Code Info20220921
Recall Initiation Date20220727
Report Date20220921
Classification Date20220915
Address355 Riverwalk Pkwy
Tonawanda, NY 14150-5837
United States
Recalling FirmPine Pharmaceuticals, LLC
Initial Notification Letter
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