Reported Nov 21, 2018 · Terminated
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01);…
Sandoz Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sandoz Inc · 100 College Rd W · Princeton, NJ · 08540-6604
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01) |
| 2 | and b) 1000-capsule bottles, (NDC 0185-0122-10) |
| 3 | Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540 |
- Lot codes and dates
- Lots
a) JB4952JA7322 Exp. 03/2020b) JA7324Exp.03/2020
- Lots
- Amount recalled
- 14366 bottles
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Cross Contamination with Other Products
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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