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Recall Observatory FDA recall evidence

Drug product

Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02

D-0380-2019

January 07, 2019

Class II

Product summary

Firm
Lupin Pharmaceuticals Inc.
Event
Event 81898
Status
Terminated
Classification
Class II
Quantity
7,215 bottles
Official record key
drug-enforcement:D-0380-2019

Official wording

Reason: CGMP Deviation; manufacturing batch record could not be located

Code information: lot # F602820, Expiry December 2019

Distribution pattern: Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviation