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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
EMD Chemicals Inc
Lot Codes / Batch Numbers
Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
Products Sold
Item # 660/75 Lot 7161(1 liter bottle) Item 660/85, Lot 7161(4 liter bottle) Exp. Date: 31 Jan 09
EMD Chemicals Inc is recalling Harleco May and Grunwald's Stain; 0.17% w/v; Methanol Solution UN1230; EMD Chemicals Inc. An Affilif due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN
Page updated: Jan 10, 2026