Drug 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,
D-1515-2016
Product summary
- Event
- Event 75083
- Status
- Terminated
- Classification
- Class III
- Quantity
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
- Official record key
drug-enforcement:D-1515-2016
Official wording
Reason: Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Code information: Lot #: AS1413A, AS1414A; Exp. 11/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Label Error