notyard
10-25-2008, 10:22 AM
U.S. FDA class II recall:
PRODUCT
Micardis® HCT (telmisartan and hydrochlorothiazide) Tablets, 40mg/12.5mg, 7-tablet blister strip in folding carton, professional sample, Rx-only, NDC 0597-0043-70, Recall # D-012-2009
CODE
Lot 605396A, exp. May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on September 16, 2008.
Manufacturer: Boehringer Ingelheim Roxane Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
Professional sample folding cartons labeled Micardis® HCT 40mg/12.5mg may contain blister strip for Micardis® HCT 80mg/12.5mg tablets which could result in double intended dose of telmisartan.
VOLUME OF PRODUCT IN COMMERCE
103,284 units
DISTRIBUTION
Nationwide
PRODUCT
Micardis® HCT (telmisartan and hydrochlorothiazide) Tablets, 40mg/12.5mg, 7-tablet blister strip in folding carton, professional sample, Rx-only, NDC 0597-0043-70, Recall # D-012-2009
CODE
Lot 605396A, exp. May 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, by letters on September 16, 2008.
Manufacturer: Boehringer Ingelheim Roxane Inc., Columbus, OH. Firm initiated recall is ongoing.
REASON
Professional sample folding cartons labeled Micardis® HCT 40mg/12.5mg may contain blister strip for Micardis® HCT 80mg/12.5mg tablets which could result in double intended dose of telmisartan.
VOLUME OF PRODUCT IN COMMERCE
103,284 units
DISTRIBUTION
Nationwide