Drug recall D-1470-2016
Product
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Reason for recall
Superpotent drug: Out of specification test result for assay during stability testing.
Lots and codes
Lot # 35434158A, Exp 6/17
Recall details
- Recalling firm
- Teva North America, Horsham, PA
- Quantity
- 53,328 bottles
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 24, 2016
- Terminated
- February 7, 2017
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.