Class II
Terminated
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
This recall has been terminated (originally issued August 31, 2016).
- Company
- Teva North America
- Recall Initiated
- June 24, 2016
- Posted
- August 31, 2016
- Recall Number
- D-1470-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 53,328 bottles
- Firm Location
- Horsham, PA, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent drug: Out of specification test result for assay during stability testing.
Distribution
Nationwide
Lot / Code Info
Lot # 35434158A, Exp 6/17
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