Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.
This recall has been terminated (originally issued March 26, 2003).
- Company
- Emd Chemicals Inc
- Recall Initiated
- December 13, 2002
- Posted
- March 26, 2003
- Terminated
- May 8, 2003
- Recall Number
- Z-0683-03
- Quantity
- 279 cases of 10 ampules
- Firm Location
- Gibbstown, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL.
Distribution
The Ethanol Products were distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Hawaii Chemical Co., 2363 North King Street, Honolulu, HI 96819; Krackeler Scientific Inc., 57 Broadway, Albany, NY 12202; Midland Scientific Inc., 1202 South 11th St., Omaha, NE 68108; Reagents, Inc. 4746 Sweden Rd., Charlotte, NC 28224. The Papanicolaou Stain was distributed nationwide by the following distributors: VWR International, 1310 Goshen Pkwy, West Chester, PA 19380; Fisher Scientific, 2000 Park Lane, Pittsburgh, PA 15275; Kramer Scientific, 711 Executive Blvd, Valley Cottage, NY 10989; Laboratory Supply Company, 3069 Mercury Rd., Jacksonville, FL 32207; Allegiance Healthcare, 1430 Waukegan Rd., McGaw Park, IL 60085; Infolab, 3000 Greenhill Dr., Round Rock, TX 78664; Government Scientific, 8460 K-Tyco Road, Vienna, VA 22182.
Lot / Code Info
Item # 68996/95 Lot #1295; Exp. Date April 30,2004
Root Cause
Other
Action Taken
All customers were nofitied by phone and letter. The first notification occurred on 12/17/2002 followed with additional notifications on 1/24/2003, 1/28/2003, and 2/4/2003.