Sodium Chloride 0 — Class II drug recall D-1064-2020
Terminated recall by Fresenius Medical Care Holdings, Inc., reported 2020-03-25, distributed nationwide. CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
| Recall number | D-1064-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Medical Care Holdings, Inc., Waltham, MA, United States |
| Recall initiated | 2020-03-05 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2023-02-03 |
| Distributed | Nationwide (US) |
| Quantity | 32,592 bags |
| Reason classes | chemical contamination, cgmp |
| Lot numbers | 19DG02050, 19EG02012, 19EG02019 |
| Expiration dates | 2020-04, 2020-05 |
Product
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, Rx only, Manufactured by: Fresenius Medical Care North America, Waltham, MA 02451
Reason for recall
CGMP Deviation: Chemical indicators were not positioned properly during sterilization process.
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-1064-2020. 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.