Recalls / Class III
Class IIID-0262-2019
Product
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
- Affected lot / code info
- Lot #: JA7319, JA 7320, JA7321, 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
- 23053 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-0262-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.