PlainRecalls
FDA Drug Low Class III Terminated

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.

Reported: December 5, 2018 Initiated: November 7, 2018 #D-0284-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
RemedyRepack Inc.
Units Affected
3,148 capsules
Distribution
Product was distributed to two medical facilities in Pennsylvania.
Location
Indiana, PA

Frequently Asked Questions

What product 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.. Recalled by RemedyRepack Inc.. Units affected: 3,148 capsules.
Why was this product recalled? ▼
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2018. Severity: Low. Recall number: D-0284-2019.

Related Recalls

FDA Drug Moderate

Bisoprolol Fumarate and Hydrochlorothiazide tablets, USP, 2.5 mg/6.25 mg, 100-count bottle, Rx Only, Manufactured by: U…

Unichem Pharmaceuticals USA Inc. · 2026-02-11
FDA Drug Critical

Green Lumber Natural Fuel For Men capsule, packaged in 2, 4, 10, and 30-count blister packs. GreenLumber.com, 2618 San…

Green Lumber Holdings, LLC · 2026-02-11
FDA Drug Moderate

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500…

Granules Pharmaceuticals Inc. · 2026-02-11
FDA Drug Critical

Diclofenac Sodium, Topical Gel, 3%, 100 g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1…

SUN PHARMACEUTICAL INDUSTRIES INC · 2026-02-11
FDA Drug Critical

Rheumacare capsules, 30 count bottle, Mfg in India by: Virgo UAP Pharma Pvt. Ltd., Ahmedabad, India UPC 8 904218 700313

HANDELNINE GLOBAL LLC · 2026-02-11

Explore Related Data

Vehicle Safety → Drug Information →