Drug recall D-803-2013
Product
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.
Reason for recall
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.
Lots and codes
Lot #s: a) 35426557A, 35426558A, Exp 08/14; b) 35426554A, 35426555A, 35426556A, Exp 08/14
Recall details
- Recalling firm
- Teva Pharmaceuticals USA, Inc., Sellersville, PA
- Quantity
- 109,080 Bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 18, 2013
- Terminated
- December 24, 2013
Related products
- Amoxicillin – drug information
- NDC 0093-2264 Amoxicillin · Amoxicillin 875 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2267 Amoxicillin · Amoxicillin 125 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4155 Amoxicillin · Amoxicillin 250 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3107 Amoxicillin · Amoxicillin 250 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4160 Amoxicillin · Amoxicillin 200 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2263 Amoxicillin · Amoxicillin 500 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-2268 Amoxicillin · Amoxicillin 250 mg/1 · Teva Pharmaceuticals USA, Inc.
- NDC 0093-4161 Amoxicillin · Amoxicillin 400 mg/5mL · Teva Pharmaceuticals USA, Inc.
- NDC 0093-3109 Amoxicillin · Amoxicillin 500 mg/1 · Teva Pharmaceuticals USA, Inc.