CLASS II Drug recall · Reported 18 Sep 2019 · FDA Enforcement Report
Bacteriostatic Water for Injection, USP vials recalled by Pfizer
Pfizer is recalling Bacteriostatic Water for Injection, USP vials, distributed nationwide in the US. The recall was initiated on 6 Sep 2019 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-1852-2019
- FDA event ID
- 83699
- Recalling firm
- Pfizer, New York, NY
- Brand
- Bacteriostatic Water
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Sep 2019
- FDA classified
- 12 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Sep 2019 | Recall initiated by company | |
| 12 Sep 2019 | Classified by FDA | +6 days |
| 18 Sep 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01; NDC Carton: 0409-3977-03
Where it was distributed
Nationwide US and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: W20308, Exp. Dec 1, 2019
Where was it sold?
Nationwide US and Puerto Rico
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 127| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Bacteriostatic Water recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Bacteriostatic Water for Injection, all strengths recalled by GenoGenix | GenoGenix | Sterility | Nationwide |
| Drug | CLASS II | Bacteriostatic Water for Injection, Pharm D Solutions recalled | Pharm D Solutions | Sterility | Nationwide |
| Drug | CLASS II | Bacteriostatic water for injection recalled by Martin Avenue Pharmacy | Martin Avenue Pharmacy | Sterility | Nationwide |
| Drug | CLASS II | Bacteriostatic Water for Injection recalled by Pallimed Solutions | Pallimed Solutions | Sterility | Nationwide |
| Drug | CLASS II | Bacteriostatic Water for Injection, all presentations including recalled | FVS Holdings | Sterility | Nationwide |