D-0346-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 9, 2019
- Initiation Date
- December 21, 2018
- Termination Date
- March 15, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,460 bottles
Product Description
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.
Reason for Recall
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Distribution Pattern
Nationwide in the USA and Puerto Rico.
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.