Recall Z-0133-2008 ยท KQC Stains, Hematology
EMD Chemicals Inc
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
| Date | Nov 3, 2007 (initiated Jul 30, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | 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. |
| Quantity | 26 units (1 liter), 1 unit (4 liter) |
| Distribution | Product was released to 2 distributors; one in the US, one in Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.