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Recall Observatory FDA recall evidence

Drug product

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01

D-0262-2019

November 02, 2018

Class III

Product summary

Firm
Sandoz Inc
Event
Event 81457
Status
Terminated
Classification
Class III
Quantity
23053 bottles
Official record key
drug-enforcement:D-0262-2019

Official wording

Reason: Cross Contamination with Other Products

Code information: Lot #: JA7319, JA 7320, JA7321, Exp. 03/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination with Other Products