Reported Jul 24, 2013 · Terminated
Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC…
Teva Pharmaceuticals USA, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA, Inc. · 650 Cathill Rd · Sellersville, PA · 18960-1512
Is this the product you have?
- Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only
- Manufactured in Canada byTeva Canada Limited, Toronto, Canada M1B2K9
- Manufactured forTeva Pharmaceuticals USA, Sellersville, PA 18960
- Lot codes and dates
Lot #s: a) 35426557A35426558AExp 08/14b) 35426554A35426555A35426556AExp 08/14
- Amount recalled
- 109,080 Bottles
Where it was sold
- Nationwide
Why it was recalled
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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