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.
Reported: March 14, 2018 Initiated: February 20, 2018 #D-0576-2018
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.
Reason for Recall
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Details
- Recalling Firm
- Hospira Inc. A Pfizer Company
- Units Affected
- a) 137,975 vials; b) 40,143 vials
- Distribution
- Nationwide in the USA and Puerto Rico.
- Location
- Mcpherson, KS
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc. A Pfizer Company. Units affected: a) 137,975 vials; b) 40,143 vials.
Why was this product recalled? ▼
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 14, 2018. Severity: Moderate. Recall number: D-0576-2018.
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