Recalls / Class III
Class IIID-0257-2019
Product
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
- Brand name
- Nitrofurantoin (monohydrate/macrocrystals)
- Generic name
- Nitrofurantoin (monohydrate/macrocrystals)
- Active ingredients
- Nitrofurantoin, Nitrofurantoin Monohydrate
- Route
- Oral
- NDC
- 0185-0122
- FDA application
- ANDA077066
- Affected lot / code info
- Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Why it was recalled
Cross Contamination with Other Products
Recalling firm
- Firm
- Sandoz Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 College Rd W, Princeton, New Jersey 08540-6604
Distribution
- Quantity
- 14366 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-11-02
- FDA classified
- 2018-11-20
- Posted by FDA
- 2018-11-21
- Terminated
- 2020-10-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0257-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.