Amoxicillin Powder, For Suspension
FDA Recall NDC 0143-9887
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Amoxicillin (NDC 0143-9887). A significant event, classified as Class III, was initiated on Nov 04, 2016 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.
Nov 04, 2016
Nov 30, 2016
32,102 bottles
Recall Profile & Regulatory Data
Event ID
75604
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
West-Ward Pharmaceuticals Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jun 16, 2017
Product Description
Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01
Batch or Lot Expiration Information
Lot# : AS1466A, Exp. Jan 2019
Affected Packages Involved in this Recall
0143-9886-01Product
0143-9886-50Product
0143-9886-75Product
0143-9887-01Product
0143-9887-50Product
0143-9887-75Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
