Drug product
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.
D-1606-2014
Product summary
- Event
- Event 69130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 148632 bags
- Official record key
drug-enforcement:D-1606-2014
Official wording
Reason: Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
Code information: Lot P318220, EXP 05/31/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.