Recalls / Class II
Class IID-0346-2019
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.
- Brand name
- Nitrofurantoin
- Generic name
- Nitrofurantoin
- Active ingredient
- Nitrofurantoin
- Route
- Oral
- NDC
- 43386-450
- FDA application
- ANDA201693
- Affected lot / code info
- 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.
Why it was recalled
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 23,460 bottles
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
Timeline
- Recall initiated
- 2018-12-21
- FDA classified
- 2018-12-31
- Posted by FDA
- 2019-01-09
- Terminated
- 2023-03-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0346-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.