Potassium Chloride Injection — Class II drug recall D-0256-2015
Terminated recall by Baxter Healthcare Corp., reported 2014-12-03, distributed nationwide. Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly over
| Recall number | D-0256-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-11-10 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2016-11-03 |
| Distributed | Nationwide (US) |
| Quantity | 63,360 containers |
| Reason classes | labeling, potency |
| NDC | 00338-0703, 00338-0703-41, 00338-0703-48, 00338-0705, 00338-0705-41, 00338-0705-48, 00338-0709, 00338-0709-48 |
| Lot numbers | P319160 |
| Expiration dates | 2015-06-30 |
Product
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA, NDC 0338-0709-48, Product Code 2B0826.
Reason for recall
Labeling: Label Error On Declared Strength: Bags of Potassium Chloride 10 mEq per 100 mL were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL.
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-0256-2015. 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.