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Recall Observatory FDA recall evidence

Drug product

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

D-0147-2017

November 04, 2016

Class III

Product summary

Firm
West-Ward Pharmaceuticals Corp.
Event
Event 75604
Status
Terminated
Classification
Class III
Quantity
32,102 bottles
Official record key
drug-enforcement:D-0147-2017

Official wording

Reason: Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

Code information: Lot #: AS1466A, Exp. Jan 2019

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error