Why it was recalled
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
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, NDC 43386-450-11.
Lot numbers, UPCs & expiration codes
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.
Where it was sold
Nationwide in the USA and Puerto Rico.
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-0346-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 21, 2018
- FDA report date
- Jan 9, 2019
- Quantity
- 23,460 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- LUPIN SOMERSET
Original FDA data
Every field from FDA enforcement report D-0346-2019, exactly as published.
Show all FDA fields
- City
- Somerset
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81865
- Address
- 400 Campus Dr
- Code information
- 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.
- Postal code
- 08873-1145
- Report date
- Jan 9, 2019
- Product type
- Drugs
- Recall number
- D-0346-2019
- Classification
- Class II
- Recalling firm
- LUPIN SOMERSET
- Product quantity
- 23,460 bottles
- Termination date
- Mar 15, 2023
- Reason for recall
- Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
- 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, NDC 43386-450-11.
- Distribution pattern
- Nationwide in the USA and Puerto Rico.
- Recall initiation date
- Dec 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2018