Recalls / Class II
Class IID-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
- Brand name
- Amoxicillin
- Generic name
- Amoxicillin
- Active ingredient
- Amoxicillin
- Route
- Oral
- NDCs
- 0093-2263, 0093-2264, 0093-4160, 0093-4155, 0093-4161, 0093-2267, 0093-2268, 0093-3107, 0093-3109
- FDA application
- ANDA065056
- Affected lot / code info
- Lot # 35434158A, Exp 6/17
Why it was recalled
Superpotent drug: Out of specification test result for assay during stability testing.
Recalling firm
- Firm
- Teva North America
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 53,328 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-06-24
- FDA classified
- 2016-08-24
- Posted by FDA
- 2016-08-31
- Terminated
- 2017-02-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1470-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.