Why it was recalled
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.
Lot numbers, UPCs & expiration codes
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
Where it was sold
Product was distributed to direct accounts in AL, CA, NC and NY
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1514-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 27, 2022
- FDA report date
- Sep 21, 2022
- Quantity
- a) 920 syringes; b) 3263 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pine Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1514-2022, exactly as published.
Show all FDA fields
- City
- Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 90854
- Address
- 355 Riverwalk Pkwy
- 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
- Postal code
- 14150-5837
- Report date
- Sep 21, 2022
- Product type
- Drugs
- Recall number
- D-1514-2022
- Classification
- Class II
- Recalling firm
- Pine Pharmaceuticals, LLC
- Product quantity
- a) 920 syringes; b) 3263 syringes
- Termination date
- Oct 19, 2022
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jul 27, 2022
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2022