Why it was recalled
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Product description
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
Lot numbers, UPCs & expiration codes
Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Where it was sold
Nationwide in the USA 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-0576-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 20, 2018
- FDA report date
- Mar 14, 2018
- Quantity
- a) 137,975 vials; b) 40,143 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc. A Pfizer Company
Original FDA data
Every field from FDA enforcement report D-0576-2018, exactly as published.
Show all FDA fields
- City
- Mcpherson
- State
- KS
- Status
- Terminated
- Country
- United States
- Event ID
- 79238
- Address
- 1776 Centennial Dr
- Code information
- Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
- Postal code
- 67460-9301
- Report date
- Mar 14, 2018
- Product type
- Drugs
- Recall number
- D-0576-2018
- Classification
- Class II
- Recalling firm
- Hospira Inc. A Pfizer Company
- Product quantity
- a) 137,975 vials; b) 40,143 vials
- Termination date
- Apr 2, 2020
- Reason for recall
- Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Feb 20, 2018
- Initial firm notification
- Letter
- Center classification date
- Mar 2, 2018