Recalls / Class III
Class IIID-0147-2017
Product
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
- Brand name
- Amoxicillin
- Generic name
- Amoxicillin
- Active ingredient
- Amoxicillin
- Route
- Oral
- NDCs
- 0143-9886, 0143-9887
- FDA application
- ANDA065325
- Affected lot / code info
- Lot #: AS1466A, Exp. Jan 2019
Why it was recalled
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Recalling firm
- Firm
- West-Ward Pharmaceuticals Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 401 Industrial Way West, N/A, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 32,102 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-04
- FDA classified
- 2016-11-22
- Posted by FDA
- 2016-11-30
- Terminated
- 2017-06-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0147-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.