Bacteriostatic Water for Injection — Class II drug recall D-1852-2019
Terminated recall by Pfizer Inc., reported 2019-09-18, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-1852-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pfizer Inc., New York, NY, United States |
| Recall initiated | 2019-09-06 |
| Classified | 2019-09-12 |
| Reported by FDA | 2019-09-18 |
| Terminated | 2023-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 185,700 vials |
| Reason classes | sterility |
| NDC | 00409-1093, 00409-1093-04, 00409-1093-14, 00409-3977, 00409-3977-01, 00409-3977-03 |
| Lot numbers | W20308 |
| Expiration dates | 2019-12-01 |
Product
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
Reason for recall
Lack of Assurance of Sterility
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1852-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.