EMD Chemicals Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
EMD Chemicals Inc
Lot Codes / Batch Numbers
Item number 68991/95, Lot number 7285 Expiration Date: April 30, 2010.
Products Sold
Item number 68991/95; Lot number 7285 Expiration Date: April 30, 2010.
EMD Chemicals Inc is recalling EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item n due to Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect concentration: 2 ampules measuring 2.0 mg/ml were found in a lot of 20 ampules of 1.0 mg/ml Ethanol Standard.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026