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Recall Observatory FDA recall evidence

Drug product

Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601

D-0635-2017

March 07, 2017

Class III

Product summary

Firm
Alvogen, Inc
Event
Event 76664
Status
Terminated
Classification
Class III
Quantity
N/A
Official record key
drug-enforcement:D-0635-2017

Official wording

Reason: Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib

Code information: Lot #: BXHD7U1A, Exp. 10/2018

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib