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Recall Observatory FDA recall evidence

Drug product

Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60 count (NDC 7133517954), and c) #90 count (NDC 7133517957) bottles, Rx only, Prinston Laboratories, Packaged by Bryant Ranch Prepack Burbank, CA 91504

D-0092-2022

October 12, 2021

Class I

Product summary

Firm
Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Event
Event 88861
Status
Completed
Classification
Class I
Quantity
a) 124, b) 29, c) 73
Official record key
drug-enforcement:D-0092-2022

Official wording

Reason: Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets

Code information: Lot #: 163935, Exp: 10/31/2022

Distribution pattern: Nationwide in the US

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error