FDA Drug recall D-0576-2018
Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I…
- FDA Drug
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, I… by Hospira A Pfizer, citing defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0576-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-20 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hospira A Pfizer |
| Distribution | US |
Product
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
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Identifiers
| ndc | 0409-2267-20 |
|---|---|
| ndc | 0409-2267-54 |
| ndc | 0409-0125-01 |
| ndc | 0409-0125-25 |
| ndc | 0409-2267-25 |
| code_info | Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2018%22
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