Recalls / Class III
Class IIID-1515-2016
Product
Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, PO Box 182400, Amman 11118 - Jordan, Distributed by: West-Ward Pharmaceutical Corp. Eatontown, NJ 07724, NDC 00143-9887-01,
- Affected lot / code info
- Lot #: AS1413A, AS1414A; Exp. 11/18
Why it was recalled
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Recalling firm
- Firm
- West-Ward Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 401 Industrial Way West, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-08-18
- FDA classified
- 2016-09-19
- Posted by FDA
- 2016-09-28
- Terminated
- 2017-09-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1515-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.