FDA-Drug2018-11-21Class III

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540

Sandoz Inc
Hazard

Cross Contamination with Other Products

Sold states
Nationwide within the United States
Affected count
14366 bottles
Manufactured in
100 College Rd W, Princeton, NJ, United States
Products
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2019

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