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Recall Observatory FDA recall evidence

Drug product

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

D-0753-2022

March 21, 2022

Class II

Product summary

Firm
Sandoz, Inc
Event
Event 88937
Status
Terminated
Classification
Class II
Quantity
7908 bottles(790,800 extended release tablets)
Official record key
drug-enforcement:D-0753-2022

Official wording

Reason: CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

Code information: Lot #: JX6411, JX6413, Exp. 05/2022 Lot #: KC0723,KC3303, Exp. 08/2022 Lot #: KE4348, KE7169,KE4349, Exp. 11/2022 Lot #: KL3199, KM0072,KS3939, Exp. 03/2023 Lot #: LA7704, LA7703,LA9243, Exp. 11/2023

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Nitrosamine impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations