Pine Pharmaceuticals, LLC: Drug Recall
Recall #D-1514-2022 · 07/27/2022
Class II: Risk
Recall Details
- Recall Number
- D-1514-2022
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Pine Pharmaceuticals, LLC
- Status
- Terminated
- Date Initiated
- 07/27/2022
- Location
- Tonawanda, NY, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 920 syringes; b) 3263 syringes
Reason for Recall
Lack of Assurance of Sterility
Product 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.
Distribution Pattern
Product was distributed to direct accounts in AL, CA, NC and NY
Other Recalls by Pine Pharmaceuticals, LLC
- Class II: Risk 10/02/2023
- Class II: Risk 10/02/2023
- Class II: Risk 10/02/2023
- Class II: Risk 10/02/2023
- Class II: Risk 10/02/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.