Why it was recalled
Failed dissolution specifications
Product description
Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
Lot numbers, UPCs & expiration codes
Lot # 471976, Exp 03/2020
Where it was sold
Natonwide, PR
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-1722-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 24, 2019
- FDA report date
- Aug 21, 2019
- Quantity
- 2784 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-1722-2019, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 83434
- Address
- 10 Bloomfield Ave Bldg B Ste 2
- Code information
- Lot # 471976, Exp 03/2020
- Postal code
- 07058-9743
- Report date
- Aug 21, 2019
- Product type
- Drugs
- Recall number
- D-1722-2019
- Classification
- Class II
- Recalling firm
- Alvogen, Inc
- Product quantity
- 2784 bottles
- Termination date
- Aug 4, 2021
- Reason for recall
- Failed dissolution specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01
- Distribution pattern
- Natonwide, PR
- Recall initiation date
- Jul 24, 2019
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2019