July 11, 2001UDL Laboratories, Inc Recalls
Film Coated Aspirin Tablets
NOTE: When this recall was originally
posted it listed the manufacturer as the recalling firm. As noted in the headline
above the company that is actually recalling the product is UDL Laboratories.
DC (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that UDL Laboratories, Inc., Rockford, IL is
recalling certain lot(s) of Aspirin Tablets, Film Coated, 325 mg. (5 gr); an OTC analgesic
because the product failed dissolution specifications (at stability testing).
This is the first public notice of
this Class III
recall issued by FDA.
PRODUCT AND CODE
Aspirin Tablets, Film Coated, 325 mg. (5 gr); an OTC analgesic; Packaged in Robot
Ready blister packages of 25 and unit dose blister packages of 100, 200 and 500.
Lots 0H624, 0P219, 1C014, 0H616, 0K043, 0P237, 1C991, 1C044, 0F530, 0K971, 1C982, 0F524,
Failed dissolution specifications (at stability testing).
LNK International, Inc., Hauppage, NY
UDL Laboratories, Inc., Rockford, IL, sent recall letters dated 6/15/01 to the 174 direct
accounts on 6/14/01 via first class mail to the attention of the Pharmacist / Inventory
FIRM INITIATED RECALL
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.