FDA Drug recall D-1852-2019
Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01
- FDA Drug
- Class II
- terminated
- Published 2019-09-18
On 2019-09-18 the FDA classified a Class II recall of Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC Vial: 0409-3977-01 by Pfizer, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1852-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-06 |
| Published | 2019-09-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
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
Lack of Assurance of Sterility
Identifiers
| ndc | 0409-3977-01 |
|---|---|
| ndc | 0409-3977-03 |
| ndc | 0409-1093-14 |
| ndc | 0409-1093-04 |
| code_info | Lot #: W20308, Exp. Dec 1, 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1852-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.