Why it was recalled
Lack of Assurance of Sterility
Product description
Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
Lot numbers, UPCs & expiration codes
Lots: LB1020A, LB1022A Exp. 5/21/2022; LB2003A, Exp. 8/5/2022; LB2007A, Exp. 9/20/2022
Where it was sold
Nationwide in the USA
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-0961-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 18, 2022
- FDA report date
- Jun 8, 2022
- Quantity
- 115640 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Nephron Sterile Compounding Center LLC
Original FDA data
Every field from FDA enforcement report D-0961-2022, exactly as published.
Show all FDA fields
- City
- West Columbia
- State
- SC
- Status
- Terminated
- Country
- United States
- Event ID
- 90211
- Address
- 4500 12th Street Ext
- Code information
- Lots: LB1020A, LB1022A Exp. 5/21/2022; LB2003A, Exp. 8/5/2022; LB2007A, Exp. 9/20/2022
- Postal code
- 29172-3025
- Report date
- Jun 8, 2022
- Product type
- Drugs
- Recall number
- D-0961-2022
- Classification
- Class II
- Recalling firm
- Nephron Sterile Compounding Center LLC
- Product quantity
- 115640 syringes
- Termination date
- Aug 23, 2024
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL Pre-Filled Syringe, 5 x 4 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-946-04
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- May 18, 2022
- Initial firm notification
- Letter
- Center classification date
- May 27, 2022