labetalol HCl injection 20 mg/4 mL recall: Labeling Error
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC…
Why was labetalol HCl injection 20 mg/4 mL recalled?
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
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 1217000213, exp 03/27/2019
- Product
- labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC…
- Recalling firm
- SCA Pharmaceuticals, LLC.
- Quantity
- 480 syringes
- Distribution
- GA, NE & PA
- Recall date
- March 14, 2018
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)