D-0576-2018 Class II Terminated
FDA drug recall D-0576-2018 was initiated by Hospira Inc. A Pfizer Company on Feb 20, 2018 and is designated Class II. Reason for recall: Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal. The recall status is terminated (terminated Apr 2, 2020). Affected quantity: a) 137,975 vials; b) 40,143 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Mar 14, 2018
- Initiation Date
- Feb 20, 2018
- Termination Date
- Apr 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 137,975 vials; b) 40,143 vials
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.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
Code Information
Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0576-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026