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.
Other recalls by Hospira A Pfizer
- Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx On…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409…
FDA Drug · Class II · 2017-08-09 · Hospira A Pfizer - Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Only, Sterile, Manufactured by: Gland Pharma Limited, Hyderabad,…
FDA Drug · Class III · 2017-07-26 · Hospira A Pfizer
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0576-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.