FDA-Drug2013-07-24Class III

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 by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.

Teva Pharmaceuticals USA, Inc.
Hazard

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.

Sold states
Nationwide
Affected count
109,080 Bottles
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
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 by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-803-2013

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