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,
Reported: September 28, 2016 Initiated: August 18, 2016 #D-1515-2016
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.
Details
- Recalling Firm
- West-Ward Pharmaceuticals Corp.
- Units Affected
- 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A)
- Distribution
- Nationwide
- Location
- Eatontown, NJ
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by West-Ward Pharmaceuticals Corp.. Units affected: 32,006 bottles (AS1413A) and 32,198 bottles (AS1414A).
Why was this product recalled? ▼
Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of the product is displayed.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 28, 2016. Severity: Low. Recall number: D-1515-2016.
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