labetalol HCl 20 mg/4mL Injection recall: Sterility Concern
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC…
Why was labetalol HCl 20 mg/4mL 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 #: 1223047334 Exp 12/23/23; 1223048170 Exp 02/01/24
- Product
- labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC…
- Recalling firm
- SCA Pharmaceuticals, LLC
- Quantity
- 2,458, syringes
- Distribution
- Nationwide in the USA
- Recall date
- April 3, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)