Why it was recalled
Cross Contamination with Other Products
Product description
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
Lot numbers, UPCs & expiration codes
Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
Where it was sold
Nationwide within the United States
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-0257-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 2, 2018
- FDA report date
- Nov 21, 2018
- Quantity
- 14366 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sandoz Inc
Original FDA data
Every field from FDA enforcement report D-0257-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81457
- Address
- 100 College Rd W
- Code information
- Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020
- Postal code
- 08540-6604
- Report date
- Nov 21, 2018
- Product type
- Drugs
- Recall number
- D-0257-2019
- Classification
- Class III
- Recalling firm
- Sandoz Inc
- Product quantity
- 14366 bottles
- Termination date
- Oct 2, 2020
- Reason for recall
- Cross Contamination with Other Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Nov 2, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 20, 2018