niCARdipine Hydrochloride Injection 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…
Why was niCARdipine Hydrochloride Injection recalled?
Lack of Assurance of Sterility.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 23087N0C0, Exp. Date 11/2024
- 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 date
- May 29, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)