Drug 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.
D-1514-2022
Product summary
- Event
- Event 90854
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 920 syringes; b) 3263 syringes
- Official record key
drug-enforcement:D-1514-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 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
Distribution pattern: Product was distributed to direct accounts in AL, CA, NC and NY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility