Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilifate of Merck KGaA Da

FDA device recall Z-0133-2008 · posted 2007-11-03 · Terminated

Recall details

Recalling firm

EMD Chemicals Inc

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.

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.

Root cause

Employee error

Status

Terminated

Product code

KQC

Quantity affected

26 units (1 liter), 1 unit (4 liter)

Distribution

Product was released to 2 distributors; one in the US, one in Canada

Date initiated

2007-07-30

Date posted

2007-11-03

Date terminated

2007-12-26

Location

Gibbstown, NJ