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.
This recall has been terminated (originally issued September 21, 2022).
- 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
- Official Source
- View on FDA website ↗
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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