September 20, 2000SmithKline Beecham
Pharmaceuticals Recalls Certain Lots of Augmentin
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) has announced that SmithKline Beecham Pharmaceuticals, NA is
recalling its Augmentin(r) Oral Suspension (Amoxicillin 400mg/Clavulanate Potassium 57
mg), 400 mg/5mL, in 100 mL multi-dose bottles because subpotency of Clavulanic Acid (9
month stability station).
This is the first public notice of
this Class II
recall issued by FDA.
Augmentin(r) Oral Suspension (Amoxicillin 400mg/Clavulanate Potassium 57 mg), 400
mg/5mL, in 100 mL multi-dose bottles. PAR NDC #49884-469-05.
Lot #MR2754 EXP 2/01.
SmithKline Beecham Pharmaceuticals, Bristol, Tennessee.
SmithKline Beecham Pharmaceuticals, NA Philadelphia, Pennsylvania, by letter August 22,
2000. Firm-initiated recall ongoing.
59,940 units were distributed.
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