Nitrofurantoin Oral Suspension recall: Subpotent
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured…
Why was Nitrofurantoin Oral Suspension recalled?
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873; Manufactured…
- Recalling firm
- LUPIN SOMERSET
- Quantity
- 23,460 bottles
- Distribution
- Nationwide in the USA and Puerto Rico.
- Recall date
- January 9, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)