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.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Emd Chemicals Inc
- Recall Initiated
- March 27, 2008
- Posted
- September 16, 2008
- Terminated
- September 22, 2008
- Recall Number
- Z-1607-2008
- Quantity
- 99 cases (10 ampules per case)
- Firm Location
- Gibbstown, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Item number 68991/95; Lot number 7285 Expiration Date: April 30, 2010.
Root 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.
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