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Terminated

Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. The product is used as a pregnancy test.

FDA Recall Z-1018-2010 · Posted 2010-03-08

Recalling FirmMainline Technology, Inc.
Recall StatusTerminated
Product CodeLCX
Date Initiated2009-10-07
Date Terminated2011-02-04
Product QuantityInformation not provided.

Reason for Recall

Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.

Firm Action

Consignees were notified via recall letters dated October 7, 2009 to cease using and to return the recalled products to Mainline Technology. Direct questions about the recall to Mainline Technology by calling 1-800-541-4467 or 1-734-930-2043.

Root Cause

PMA

Distribution Pattern

Worldwide Distribution -- United States, Belgium and Switzerland.

Official Source

View FDA Recall →

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

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