SODIUM CHLORIDE INJECTION — Class I drug recall D-0298-2019
Terminated recall by Fresenius Kabi USA, LLC, reported 2018-12-12, distributed nationwide. Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the p
| Recall number | D-0298-2019 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Grand Island, NY, United States |
| Recall initiated | 2018-11-15 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2023-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 23,745,300 |
| Reason classes | labeling |
| NDC | 63323-0186, 63323-0186-01, 63323-0186-02, 63323-0186-03, 63323-0186-04, 63323-0186-10, 63323-0186-20 |
| Lot numbers | 6013062, 6013112, 6013113, 6013114, 6013180, 6013181, 6013182, 6013237, 6013238, 6013239, 6013468, 6013512, 6013513, 6013551, 6013552, 6013553, 6013607, 6013608, 6013610, 6013627, 6013678, 6013679, 6013822, 6013823, 6013824, 6013924, 6013925, 6013926, 6014003, 6014004, 6014005, 6014162, 6014163, 6014164, 6014260, 6014301, 6014302, 6014303, 6014304, 6014305 and 124 more |
Product
SODIUM CHLORIDE INJECTION, USP, 0.9%, 10 mL Single Dose Vial, packaged in a 25-unit tray, Rx Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173. NDC 63323-186-10 Product code 918610
Reason for recall
Labeling Not Elsewhere Classified: Fresenius Kabi is taking this action due to an incorrect statement on the product insert for product codes 918610 and 918620 indicating that the stoppers do not contain natural rubber latex. The tray label for these two product codes and the vial label for product code 918620 also incorrectly state that the stoppers do not contain latex. The above listed product codes and batches being recalled have stoppers containing natural rubber latex.
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-0298-2019. 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.