Why it was recalled
Lack of Assurance of Sterility.
Product description
niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
Lot numbers, UPCs & expiration codes
Lot #: 23087N0C0, Exp. Date 11/2024
Where it was sold
UT only
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-0503-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 14, 2024
- FDA report date
- May 29, 2024
- Quantity
- 4,136 cartons (10 vials in each carton)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Regent, Inc.
Original FDA data
Every field from FDA enforcement report D-0503-2024, exactly as published.
Show all FDA fields
- City
- New Albany
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 94621
- Address
- 6610 New Albany Rd E
- Code information
- Lot #: 23087N0C0, Exp. Date 11/2024
- Postal code
- 43054-8730
- Report date
- May 29, 2024
- Product type
- Drugs
- Recall number
- D-0503-2024
- Classification
- Class II
- Recalling firm
- American Regent, Inc.
- Product quantity
- 4,136 cartons (10 vials in each carton)
- Termination date
- Dec 23, 2025
- Reason for recall
- Lack of Assurance of Sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- niCARdipine Hydrochloride Injection, USP, 25 mg/10 mL (2.5 mg/mL), 10 x 10 mL Single Dose Vials, Rx Only, For Intravenous Use Only, Mfd for: Civica, Inc., Lehi, UT 84043; Mfd by: American Regent, Inc., New Albany, OH 43054. NDC 72572-470-10
- Distribution pattern
- UT only
- Recall initiation date
- May 14, 2024
- Initial firm notification
- Letter
- Center classification date
- May 21, 2024