Why it was recalled
Subpotent Drug and Failed Content Uniformity.
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, UPC 343386-450-114, NDC 43386-450-11
Lot numbers, UPCs & expiration codes
Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
Where it was sold
Nationwide within the US
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0927-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 28, 2018
- FDA report date
- Jul 18, 2018
- Quantity
- 3456 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-0927-2018, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80377
- Address
- 400 Campus Dr
- Code information
- Lot#: S700065, Exp. 02/2019; 700619, Exp. 08/2019
- Postal code
- 08873-1145
- Report date
- Jul 18, 2018
- Product type
- Drugs
- Recall number
- D-0927-2018
- Classification
- Class II
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 3456 cartons
- Termination date
- Mar 6, 2023
- Reason for recall
- Subpotent Drug and Failed Content Uniformity.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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, UPC 343386-450-114, NDC 43386-450-11
- Distribution pattern
- Nationwide within the US
- Recall initiation date
- Jun 28, 2018
- Initial firm notification
- Letter
- Center classification date
- Jul 18, 2018