Reported Jan 9, 2019 · Terminated
Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only, Manufactured by: Novel Laboratories, Inc.,…
Lupin Somerset
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LUPIN SOMERSET · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
- Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL bottle, Rx only
- Manufactured byNovel Laboratories, Inc., Somerset, NJ 08873
- Manufactured forLupin Pharmaceuticals, Inc., Baltimore, MD 21202, NDC 43386-450-11
- Lot codes and dates
6 of 6 products
Products covered by this recall # Product as published 1 S700038, S700044, S700059, S700065, Exp 28-Feb-19 2 S700410, S700427, Exp 30-Jun-19 3 S700617, S700619, Exp 31-Aug-19 4 S700813, S700815, S700869, Exp 31-Oct-19 5 S700871, S700873, Exp 30-Nov-19 6 S700875, S701073, Exp 31-Dec-19. - Amount recalled
- 23,460 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Lupin Somerset recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.