D-1514-2022 Class II Terminated
FDA drug recall D-1514-2022 was initiated by Pine Pharmaceuticals, LLC on July 27, 2022 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated October 19, 2022). Affected quantity: a) 920 syringes; b) 3263 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 21, 2022
- Initiation Date
- July 27, 2022
- Termination Date
- October 19, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 920 syringes; b) 3263 syringes
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.
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Product was distributed to direct accounts in AL, CA, NC and NY
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