FDAClass IIJune 27, 2012

Heparin Lock Flush Solution recall: CGMP Deviations

HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx…

Why was Heparin Lock Flush Solution recalled?

CGMP Deviations: Incomplete documentation associated with test results.

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 406952 (Expiration Date 02/11)

Product
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx…
Recalling firm
App Pharmaceuticals Llc
Quantity
133,150 vials
Distribution
Nationwide Distribution and Puerto Rico
Recall date
June 27, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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