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Recall Observatory FDA recall evidence

Drug product

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

D-0007-2023

September 14, 2022

Class III

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
Event
Event 90868
Status
Completed
Classification
Class III
Quantity
2,838 ampules
Official record key
drug-enforcement:D-0007-2023

Official wording

Reason: Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Code information: Lot # ACB101, Exp 03/2023

Distribution pattern: USA nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification