From FDA Enforcement Report for May 31, 2006

Recall Level:
Class III (violates FDA labeling or manufacturing regulations, but unlikely to cause any adverse health reaction)

Date of Recall:
May 4, 2006

Product Recalled:

Mardel Maracyn® Freshwater antibiotic (Erythromycin) tablets

• each tablet contains 200 mg. erythromycin activity
• packaged 24 tablets in blister strips per inner folding carton
• Item #01120

Code:
Lot 051617

Problem/Reason for Recall:
During a packaging run, approximately 5% of the Maracyn (erythromycin) tablets were packaged in Tetracycline tablet inner folding cartons (Item #16120) that were accidentally intermixed with the Maracyn inner folding cartons (Item #01120). Although the master cases were correctly labeled "VIRBAC Maracyn 24 FW Tabs" and intermediate cases (6 per master case) were also properly identified as "Maracyn," some of the blister strips containing Maracyn tablets may have been inserted into inner folding cartons labeled Tetracycline tablets.

The code "Lot 051617" was stamped on both the blister strips and on the inner folding cartons, including the Tetracycline cartons that were used.

Both Mardel Maracyn® Freshwater antibiotic (Erythromycin) tablets and Mardel Tetracycline Tablets antibiotic tablets are indicated to treat many of the same fish diseases.

The 24-count inner folding cartons look like this:

Recalling Firm:
Virbac AH, Inc.
Fort Worth, TX

Recalling Manufacturer:
Virbac Corp.
Bridgeton, MO

Customer Questions and Concerns:
Customers with questions or concerns should contact Virbac AH, Inc. Customer Service at 1-800-338-3659 ext. 3510 or ext. 3530.

Customer Returns:
Customers who purchased Mardel Tetracycline Tablets antibiotic tablets with the code Lot 051617 , may return them to the store where they were purchased. The tablets in these packages are actually Mardel Maracyn® Freshwater antibiotic (Erythromycin) tablets.

Amount Recalled:
43 master cases (containing 3,096/24-tablet inner folding cartons)

Distribution:
NY, CA, FL, PA, WI, OH, NJ, IL, NC, MI and Canada

Press Release: No