Recall Z-1607-2008
EMD Chemicals Inc · initiated March 27, 2008
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.
Codes / lots: Item number 68991/95; Lot number 7285 Expiration Date: April 30, 2010.
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1607-2008
- Initiated
- March 27, 2008
- Posted by FDA
- September 16, 2008
- Terminated
- September 22, 2008
- Product code
- DNN – Calibrators, Ethyl Alcohol
- Quantity
- 99 cases (10 ampules per case)
- Distribution
- Nationwide Distribution.
- Recalling firm
- EMD Chemicals Inc, Gibbstown, NJ