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Recall Observatory FDA recall evidence

Drug product

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79

D-0166-2020

September 23, 2019

Class III

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 83868
Status
Ongoing
Classification
Class III
Quantity
69696 bottles
Official record key
drug-enforcement:D-0166-2020

Official wording

Reason: CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Code information: Lot #: NBSB19001DA3, Exp. date 02/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP DEVIATIONS