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-

FDA recall notice · announced September 28, 2016 · West-ward Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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,

Reason for recall

Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.

Notes

Distribution: Nationwide
Lot/code information: Lot #: AS1413A, AS1414A; Exp. 11/18
Quantity: 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
Status: Terminated
Products in this recall event:
- 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-Wa (D-1515-2016)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.