RemedyRepack Inc. recalls Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Pr…

Recall date

November 7, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0284-2019

FDA classification

Class III

Brand / firm

RemedyRepack Inc.

Sold / distributed

Product was distributed to two medical facilities in Pennsylvania.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.