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May 17, 2001

Apothecon Recalls Trimox

Plainsboro, NJ (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Apothecon, A Bristol-Myers Squibb Company has recalled certain Trimox because of microbial contamination (mold).

This is the first public notice of this Class II recall issued by FDA.

Trimox 250 mg/5 mL - 150 mL (Amoxicillin for Oral Suspension, USP), NDC 0003-1738-45, HDPE bottle (200 mL) with child resistance cap. Rx only. ANDA-61-886.

Recall #D-210-1.

OC31128, OC31131, OC31133, OD23895, OD23899, OD23901, OD23903, OD23914, OD23919, OD23925, OD23930, OD23943, OD23945, OD23948, OD23950, OD23951, OD23952, OD23954, OD23955, OD23959, OD23967, OD23968, OD23969, OD23971, OD23983, OD23986, OD27582, OD27587, OD27592, OD27602, OD27607, OD27619, OD27626, OD27723, OD27727, OD27750. 

Exp. Date for all lots is October 2002

Apothecon, A Bristol-Myers Squibb Company, Plainsboro, NJ.

Manufacturer, by letters dated 4/5/01. Firm-initiated recall ongoing.


831, 267 bottles.

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.