May 17, 2001Apothecon Recalls Trimox
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.
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.