D-1515-2016 Class III Terminated
FDA drug recall D-1515-2016 was initiated by West-Ward Pharmaceuticals Corp. on Aug 18, 2016 and is designated Class III. Reason for recall: Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed. The recall status is terminated (terminated Sep 1, 2017). Affected quantity: 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A).
Recall details
- Product Type
- Drugs
- Report Date
- Sep 28, 2016
- Initiation Date
- Aug 18, 2016
- Termination Date
- Sep 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
Product description
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,
Reason for recall
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Distribution pattern
Nationwide
Code information
Lot #: AS1413A, AS1414A; Exp. 11/18
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1515-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026