Safety Alerts Saves Lives
Safety Alerts  
 
Home Privacy About Us Contact Us Change Preferences

SafetyAlerts
September 20, 2000

SmithKline Beecham Pharmaceuticals Recalls Certain Lots of Augmentin

Philadelphia, 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.

PRODUCT
Augmentin(r) Oral Suspension (Amoxicillin 400mg/Clavulanate Potassium 57 mg), 400 mg/5mL, in 100 mL multi-dose bottles. PAR NDC #49884-469-05.

Recall #D-465-0.

CODE
Lot #MR2754 EXP 2/01.

MANUFACTURER
SmithKline Beecham Pharmaceuticals, Bristol, Tennessee.

RECALLED BY
SmithKline Beecham Pharmaceuticals, NA Philadelphia, Pennsylvania, by letter August 22, 2000. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
59,940 units were distributed.

 
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?

Sign-up for SafetyAlerts by Email -
The free internet newsletter that could
some day literally save your life - or
the life of someone you know.

Safety Alerts compiles comprehensive safety recall information for the United States. SafeMail is a free email service to warn consumers of faulty products and contaminated foods. For complete information regarding current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.

###

 

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.