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Terminated

Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

FDA Recall Z-1389-2008 · Posted 2008-04-04

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeNZW
Date Initiated2008-02-28
Date Terminated2020-02-18
Product Quantity1,313,225 vials

Reason for Recall

Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products

Firm Action

A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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