Why it was recalled
Lack of Assurance of Sterility
Product description
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
Lot numbers, UPCs & expiration codes
Lot #: 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023
Where it was sold
Nationwide within the United States
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-0057-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 2, 2023
- FDA report date
- Oct 25, 2023
- Quantity
- 4972 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pine Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0057-2024, exactly as published.
Show all FDA fields
- City
- Tonawanda
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 93154
- Address
- 355 Riverwalk Pkwy
- Code information
- Lot #: 67918, Exp. Date 10/29/2023; 68033, Exp. Date 11/4/2023; 68515, Exp. Date 11/26/2023; 68528, Exp. Date 11/27/2023; 68618, Exp. Date 12/2/2023; 68651, Exp. Date 12/3/2023; 68767, Exp. Date 12/9/2023; 68829, Exp. Date 12/11/2023; 69820, Exp. Date 1/9/2024; 70733, Exp. Date 2/19/2024; 71068, Exp. Date 3/9/2024; 67345, Exp. Date 10/3/2023
- Postal code
- 14150-5837
- Report date
- Oct 25, 2023
- Product type
- Drugs
- Recall number
- D-0057-2024
- Classification
- Class II
- Recalling firm
- Pine Pharmaceuticals, LLC
- Product quantity
- 4972 syringes
- Termination date
- May 15, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY 14150.
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 2, 2023
- Initial firm notification
- Letter
- Center classification date
- Oct 19, 2023