CLASS II Drug recall · Reported 4 Oct 2017 · FDA Enforcement Report
Sterile Water for Injection, USP Single Dose vials recalled by Pfizer
Pfizer is recalling Sterile Water for Injection, USP Single Dose vials, distributed nationwide in the US. The recall was initiated on 1 Sep 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1177-2017
- FDA event ID
- 78048
- Recalling firm
- Pfizer, New York, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Sep 2017
- FDA classified
- 22 Sep 2017
- Reported
- 4 Oct 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Injectable & IV Drugs
Timeline
| 1 Sep 2017 | Recall initiated by company | |
| 22 Sep 2017 | Classified by FDA | +21 days |
| 4 Oct 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.
Which lots are affected?
Lot: 63-075-DK Exp. FEB 2019
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer
All 129| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), tablets, 175 mcg recalledLevoxyl | Pfizer | Potency & Assay | Nationwide |
| Drug | CLASS II | Dopamine HCl Inj., USP, 200 mg/ (40 mg/mL) Single-dose recalledDopamine Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ (0.1 mg/mL) recalled | Pfizer | Sterility | Nationwide |
Other Water recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Water for Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Irrigation, Single-Dose recalled by Baxter HealthcareSterile Water | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Sterile Water For Injection recalled by B Braun MedicalSterile Water | B Braun Medical | Sterility | Nationwide |
| Drug | CLASS II | Sterile Water for Injection, USP, mL Single-Dose Vials recalled | Nephron Sc | Manufacturing (CGMP) Deviations | SC |
| Drug | CLASS II | Sterile Water for Injection recalled by Nephron Sc | Nephron Sc | Manufacturing (CGMP) Deviations | Nationwide |