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.
Potassium Phosphates 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
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 Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
Affected NDC
0409-7295-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Hospira a Pfizer Company
- Origin
- NC, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1046-2017 · 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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