Labetalol 20 mg/4 mL recall: Sterility Concern
Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
Why was Labetalol 20 mg/4 mL recalled?
Lack of sterility assurance.
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?
Lots: EA241908 Exp. 4/24/2019; EB011905 Exp. 5/2/2019; EB081909 Exp. 5/9/2019; EB151910 Exp. 5/16/2019; EB251909 Exp. 5/26/2019; EC061907 Exp. 6/4/2019; EC151906 Exp. 6/13/2019
- Product
- Labetalol 20 mg/4 mL, 20 mg in 4 mL syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
- Recalling firm
- CMC Enterprise Pharmacy
- Quantity
- 6667 syringes
- Distribution
- NC
- Recall date
- May 1, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)