Recalls / Class II
Class IID-0927-2018
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, UPC 343386-450-114, 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#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Why it was recalled
Subpotent Drug and Failed Content Uniformity.
Recalling firm
- Firm
- LUPIN SOMERSET
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 3456 cartons
- Distribution pattern
- Nationwide within the US
Timeline
- Recall initiated
- 2018-06-28
- FDA classified
- 2018-07-18
- Posted by FDA
- 2018-07-18
- Terminated
- 2023-03-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0927-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.