Gentamicin Recall

PRODUCT:
Gentamicin Sulfate Solution, 100 mg/ml, each mL contains gentamicin sulfate veterinary equivalent to 100 mg gentamicin base, packaged in sterile multi-dose 100-ml bottles, 12/case, RX, ANDA 200-395, under the following brand names and labels: (1) VEDCO GentaVed 100, NDC 50989-040-12; (2) AgriLabs LEGACY, NDC 57561-336-04; (3) Phoenix Pharmaceutical, Inc. GentaMax 100, NDC 57319-520-05; (4) RXV Gentamicin Sulfate Solution; (5) VetTek Gentamicin Sulfate Solution, NDC 60270-338-10; and (6) Butler GENTAFUSE, NDC 11695-4146-1. Recall # V-188-2010

CODE:
Lot 091239, Exp. 01/2012

RECALLING FIRM/MANUFACTURER
Sparhawk Laboratories Inc., Lenexa, KS, by telephone on June 8, 2010, and by letters dated June 11, 2010. Firm initiated recall is ongoing.  

REASON
A water leak occurred in the fill room outside the filling line.

VOLUME OF PRODUCT IN COMMERCE
14,677/100-ml. bottles

DISTRIBUTION
MO, TN, and OH