niCARdipine Hydrochloride Injection 25 mg/10mL Recall: Sterility Concern
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…
What is the FDA recall status?
The FDA record lists this recall as terminated. This does not establish that a retained recalled product is safe to consume or use. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions.
Why was niCARdipine Hydrochloride Injection 25 mg/10mL recalled?
Lack of Assurance of Sterility.
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full 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
Which lot codes, UPCs or models are affected?
Lot #: 23087N0C0, Exp. Date 11/2024
- Agency record number
- D-0503-2024
- Product
- 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…
- Recalling firm
- American Regent, Inc.
- Quantity
- 4,136 cartons (10 vials in each carton)
- Distribution
- UT only
- Recall started
- May 14, 2024
- Report date
- May 29, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)