RecallDepth
Class II Terminated

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.

Company
Pine Pharmaceuticals, Llc
Recall Initiated
July 27, 2022
Posted
September 21, 2022
Recall Number
D-1514-2022
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
a) 920 syringes; b) 3263 syringes
Firm Location
Tonawanda, NY, United States

Reason for Recall

Lack of Assurance of Sterility

Distribution

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

Lot / Code Info

Lot #s: a) 58366, exp. date 09/26/2022; 60247, exp. date 12/04/2022; b) 54825, exp. date 08/10/2022; 57583, exp. date 08/22/2022; 59343, exp. date 10/30/2022; 60355, exp. date 10/11/2022

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