FDA Drug recall D-0097-2023
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59)…
- FDA Drug
- Class II
- completed
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class II recall of Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59)… by Pfizer, citing lack of assurance of sterility: Bags have the potential to leak.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0097-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-12-29 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Pfizer |
| Distribution | US |
Product
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Reason
Lack of assurance of sterility: Bags have the potential to leak.
Identifiers
| ndc | 0409-7620-13 |
|---|---|
| ndc | 0409-7620-03 |
| ndc | 0409-7620-49 |
| ndc | 0409-7620-59 |
| ndc | 0409-1005-01 |
| ndc | 0409-1005-20 |
| ndc | 0409-2222-01 |
| ndc | 0409-2222-12 |
| code_info | Lot: 5935283, Exp. 12/01/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0097-2023%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.