Class II · Moderate risk
Labetalol Hydrochloride Injection
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
8.4% Sodium Bicarbonate Inj.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Sterility Assurance
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 60045 USA, NDC: 0409-6625-02
Affected NDC
0409-6625-02
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Sodium Bicarbonate NDC 00409-6625 |
84 mg/mL | Injection, Solution Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira a Pfizer Company
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1047-2017 · 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 recalls by Hospira a Pfizer Company
All 2017 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
Other sterility / contamination recalls from 2017
All sterility / contamination recalls
Class II · Moderate risk
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Rocuronium Bromide in all strengths
Lack of sterility assurance.
Class II · Moderate risk
Methadone HCl Injection in all strengths
Lack of sterility assurance.
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