Why it was recalled
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Product description
Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
Lot numbers, UPCs & expiration codes
Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
Where it was sold
US Nationwide and Puerto Rico.
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-0565-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 20, 2024
- FDA report date
- Jul 3, 2024
- Quantity
- 220,400 cartridges
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0565-2024, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 94681
- Address
- 235 East 42nd Street
- Code information
- Lot#: HJ7566; Exp 2025/05 Lot#: HN8747; Exp 2025/09 Lot#: HN8749; Exp 2025/09
- Postal code
- 10017-5703
- Report date
- Jul 3, 2024
- Product type
- Drugs
- Recall number
- D-0565-2024
- Classification
- Class II
- Recalling firm
- Pfizer Inc.
- Product quantity
- 220,400 cartridges
- Reason for recall
- Lack of Assurance of Sterility-The potential for incomplete crimp seals.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Labetalol Hydrochloride Injection, USP, 20 mg/4 mL (5 mg/mL), 4 mL Single-dose Carpuject, Sterile Cartridge Unit with Luer Lock, For Intravenous Injection Only, Rx Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA. NDC: 0409-2339-24
- Distribution pattern
- US Nationwide and Puerto Rico.
- Recall initiation date
- May 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Jun 22, 2024