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SafetyAlerts
July 11, 2001

UDL 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.

WASHINGTON, 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, 0K963, 1C974

RECALL NUMBER
D-244-1

REASON:
Failed dissolution specifications (at stability testing).

MANUFACTURER:
LNK International, Inc., Hauppage, NY

RECALLED BY:
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 Control Manager.

FIRM INITIATED RECALL
Ongoing

DISTRIBUTION
Nationwide

QUANTITY
16,196,325 tablets.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.