Why it was recalled
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Product description
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
Lot numbers, UPCs & expiration codes
Lot # 1003829, Exp date 1/31/23
Where it was sold
Nationwide USA
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-0880-2022
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 3, 2022
- FDA report date
- May 25, 2022
- Quantity
- 1603 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0880-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 90191
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot # 1003829, Exp date 1/31/23
- Postal code
- 43217-1188
- Report date
- May 25, 2022
- Product type
- Drugs
- Recall number
- D-0880-2022
- Classification
- Class III
- Recalling firm
- American Health Packaging
- Product quantity
- 1603 cartons
- Termination date
- Sep 28, 2023
- Reason for recall
- Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01
- Distribution pattern
- Nationwide USA
- Recall initiation date
- May 3, 2022
- Initial firm notification
- Letter
- Center classification date
- May 18, 2022