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, NDC 43386-450-11.
D-0346-2019
Product summary
- Firm
- LUPIN SOMERSET
- Event
- Event 81865
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,460 bottles
- Official record key
drug-enforcement:D-0346-2019
Official wording
Reason: Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Code information: Lot #: S700038, S700044, S700059, S700065, Exp 28-Feb-19; S700410, S700427, Exp 30-Jun-19; S700617, S700619, Exp 31-Aug-19; S700813, S700815, S700869, Exp 31-Oct-19; S700871, S700873, Exp 30-Nov-19; S700875, S701073, Exp 31-Dec-19.
Distribution pattern: Nationwide in the USA and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Subpotent