FDAFDA · Food and drugs·Recall number D-803-2013
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.
Published July 24, 2013 · Recall initiated: June 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AMOXICILLIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Distributor
- Nationwide
- UPC
- 0300933107051
- Lot
- Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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