FDAClass IIIMarch 20, 2013

Calcium Gluconate Injection recall: Labeling Error

CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals…

Why was Calcium Gluconate Injection recalled?

Labeling: Missing label

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 6004889, Expiration Date 10/2014

Product
CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals…
Recalling firm
Fresenius Kabi USA LLC (FK USA)
Quantity
155,900 vials domestically
Distribution
Nationwide
Recall date
March 20, 2013
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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