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Recall Observatory FDA recall evidence

Drug product

Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Princeton, NJ, Repackaged by: RemedyRepack, Indiana, PA, Original NDC 00185-0122-01Repackaged NDC 70518-1087-00, 14 capsules in HDPE 60 cc bottles in cardboard trays & HDPE 60 cc bottles in plastic bags, Repackaged NDC 70518-1087-01, 10 capsules in HDPE 60 cc bottles in cardboard trays.

D-0284-2019

November 07, 2018

Class III

Product summary

Firm
RemedyRepack Inc.
Event
Event 81638
Status
Terminated
Classification
Class III
Quantity
3,148 capsules
Official record key
drug-enforcement:D-0284-2019

Official wording

Reason: Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).

Code information: Lot #: B0484872-081718, B0481339-081018, Exp 08/2019; B0506246-092718, Exp 09/2019; B0509938-100418, Exp 10/2019

Distribution pattern: Product was distributed to two medical facilities in Pennsylvania.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).