Class II · Moderate risk
Labetalol Hydrochloride Injection
Lack of Assurance of Sterility-The potential for incomplete crimp seals.
Labetalol Hydrochloride Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What 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.
Affected NDCs
0409-2267-20
0409-2267-25
Compare with the code on your package — it is the most precise check available.
Drug: Labetalol
- Recalling firm
- Hospira Inc. A Pfizer Company
- NDC code
- 0409-2267-20
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0576-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Labetalol recalls
See all
Class II · Moderate risk
labetalol HCl 20 mg/4mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Labetalol HCl Injection
Lack of Assurance of Sterility
Other recalls by Hospira Inc. A Pfizer Company
All 2018 recalls
Class III · Low risk
Argatroban Injection
Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-related impurity during three month time point
Class II · Moderate risk
Neut Sodium Bicarbonate 4%
Lack of Sterility Assurance
Class II · Moderate risk
Succinylcholine Chloride Injection
Lack of Sterility Assurance
Class II · Moderate risk
8.4% Sodium Bicarbonate Inj.
Lack of Sterility Assurance
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