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D-1606-2014 Class II Terminated

Recalled by Baxter Healthcare Corp — Deerfield, IL

FDA drug recall D-1606-2014 was initiated by Baxter Healthcare Corp on Sep 8, 2014 and is designated Class II. Reason for recall: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside. The recall status is terminated (terminated Sep 27, 2016). Affected quantity: 148632 bags.

Recall Details

Product Type: Drugs
Report Date: Oct 1, 2014
Initiation Date: Sep 8, 2014
Termination Date: Sep 27, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 148632 bags

Product Description

Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

Reason for Recall

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Distribution Pattern

Nationwide

Code Information

Lot P318220, EXP 05/31/15

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1606-2014
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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