Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Sterile Water for Inj.
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx only, For Drug Diluent Use Only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA, NDC Carton: 0409-4887-99; NDC Vial: 0409-4887-25
Affected NDCs
0409-4887-25
0409-4887-99
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 |
|---|---|---|---|---|
| Sterile Water Water NDC 00409-4887 |
1 mL/mL | Injection Intramuscular|intravenous|subcutaneous |
Hospira, Inc. | Rx |
- Recalling firm
- Pfizer Inc.
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0384-2021 · 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 Pfizer Inc.
All 2021 recalls
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
Other particulate / foreign matter recalls from 2021
All particulate / foreign matter recalls
Class II · Moderate risk
Metoprolol Tartrate Tablets
Complaint received of foreign matter (metal) embedded in tablet.
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class I · High risk
Cubicin (daptomycin for injection)
Presence of Particulate Matter: Identified as Glass Particles
Class II · Moderate risk
Ezetimibe and Simvastatin Tablets
Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
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