Z-1607-2008

EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number...

Name: Z-1607-2008 EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number...
Creator: EMD Chemicals Inc
Published: 2008-03-27
License: https://open.fda.gov/license/

EMD Millipore Corporation / initiated 2008-03-27 / Terminated / root cause: manufacturing process

FDA source

EMD Chemicals Inc began a recall of EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic on 2008-03-27. The reason FDA records is "Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1607-2008
Status: Terminated
Initiated: 2008-03-27
Posted: 2008-09-16
Terminated: 2008-09-22
Recalling firm: EMD Millipore Corporation
Product: EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.
Product code: DNN Calibrators, Ethyl Alcohol
Reason for recall: Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: VWR International and Thermo Fisher Scientific were notified of the recall by e-mail on 3/27/08 and asked to provide end user lists so that recall letters could be sent to each customer. Customers were sent a letter commencing April 3, 2008, by first class mail.
Quantity in commerce: 99 cases (10 ampules per case)
Distribution: Nationwide Distribution.
Product codes and lots: Item number 68991/95; Lot number 7285 Expiration Date: April 30, 2010.

Product code DNN

K990516Class IIEthyl Alcohol Clinical Standard SolutionsEmd Chemicals, Inc. / cleared 1999-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)