Drug product
Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11
D-0927-2018
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 80377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3456 cartons
- Official record key
drug-enforcement:D-0927-2018
Official wording
Reason: Subpotent Drug and Failed Content Uniformity.
Code information: Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Subpotent