notyard
07-31-2008, 12:04 AM
U.S. FDA class II recall:
PRODUCT
Paroxetine Tablets, USP. 20mg, NDC: 54458-989-10, Recall # D-237-2008
CODE
T4362A
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Laboratories, Inc., St Petersburg, FL, by letter, telephone, and e-mail on January 22, 2008.
Manufacturer: Cadila Healthcare Limited, Ahmedabad, Gujarat, India. Firm initiated recall is ongoing.
REASON
Mispacked; patient compliance pack container called (Shell Pak) labeled to contain 20mg unit of use blister cards actually contain 10mg unit of use blister cards.
VOLUME OF PRODUCT IN COMMERCE
3,798 dispensing cartons
DISTRIBUTION
Nationwide
PRODUCT
Paroxetine Tablets, USP. 20mg, NDC: 54458-989-10, Recall # D-237-2008
CODE
T4362A
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Laboratories, Inc., St Petersburg, FL, by letter, telephone, and e-mail on January 22, 2008.
Manufacturer: Cadila Healthcare Limited, Ahmedabad, Gujarat, India. Firm initiated recall is ongoing.
REASON
Mispacked; patient compliance pack container called (Shell Pak) labeled to contain 20mg unit of use blister cards actually contain 10mg unit of use blister cards.
VOLUME OF PRODUCT IN COMMERCE
3,798 dispensing cartons
DISTRIBUTION
Nationwide