Recall Z-0133-2008
EMD Chemicals Inc · initiated July 30, 2007
Product
Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Damstadt, Germany; 480 South Democrat Road; Gibbstown, NJ 08027; 1 liter and 4 liter poly bottles
Codes / lots: Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
Reason for recall
Out of Spec -- The Batch (Lot) was incorrectly released after being rejected for out of specification of high azure and eosin absorbance at the end of the run and particulate matter at the end of the run.
FDA-determined cause: Employee error
Action taken
EMD Chemicals via fax and mailed an Important Product Recall letter dated 7/30/07. The letter notified end use consignee that after conducting an investigation it has determined that Harleco May and Grunwald's Stain; 0.17% w/v Item #660/75 % 660/85 has unacceptable levels of azure and eosin absorbance and undissolved dye matter. Users were requested to discontinue shipping and return product. Wholesalers were advised this is a Customer Level Product Recall and requested to sub recall product sold after 7/5/07.
Details
- Recall number
- Z-0133-2008
- Initiated
- July 30, 2007
- Posted by FDA
- November 3, 2007
- Terminated
- December 26, 2007
- Product code
- KQC – Stains, Hematology
- Quantity
- 26 units (1 liter), 1 unit (4 liter)
- Distribution
- Product was released to 2 distributors; one in the US, one in Canada
- Recalling firm
- EMD Chemicals Inc, Gibbstown, NJ