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Recall Observatory FDA recall evidence

Drug product

Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01

D-0423-2019

January 09, 2019

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 81908
Status
Terminated
Classification
Class II
Quantity
14,400 bottles
Official record key
drug-enforcement:D-0423-2019

Official wording

Reason: CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

Code information: lot F801282, Expiry June 2020

Distribution pattern: Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    extraneous material
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations