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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1514-2022 |
| Event ID | 90854 |
| Distribution | Product was distributed to direct accounts in AL, CA, NC and NY |
| Quantity | a) 920 syringes; b) 3263 syringes |
| Recall Reason | Lack of Assurance of Sterility |
| Drug Classification | Class II |
| Drug Code Info | 20220921 |
| Recall Initiation Date | 20220727 |
| Report Date | 20220921 |
| Classification Date | 20220915 |
| Address | 355 Riverwalk Pkwy Tonawanda, NY 14150-5837 United States |
| Recalling Firm | Pine Pharmaceuticals, LLC |
| Initial Notification | Letter |
| Similar To |