Drug 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
D-0257-2019
Product summary
- Firm
- Sandoz Inc
- Event
- Event 81457
- Status
- Terminated
- Classification
- Class III
- Quantity
- 14366 bottles
- Official record key
drug-enforcement:D-0257-2019
Official wording
Reason: Cross Contamination with Other Products
Code information: Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Cross Contamination with Other Products