Labetalol 20mg recall: Labeling Error
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th…
Why was Labetalol 20mg recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that, when scanned, reveals information specific to the batch of the labeled product, including Expiration Date. The expiration date included within these 2D barcodes is incorrect and does not match the correct expiration date listed on the face of the label itself.
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?
138-20182712@49, BUD 4/6/2019; 138-20182712@63, BUD 4/6/2019; 138-20182712@89, BUD 4/6/2019; 138-20182712@90, BUD 4/6/2019; 138-20182712@93, BUD 4/6/2019; 138-20183112@88, BUD 4/10/2019; 138-20183112@89, BUD 4/10/2019;138-20183112@91, BUD 4/10/2019; 138-20190201@96, BUD 4/12/2019
- Product
- Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th…
- Recalling firm
- Avella of Deer Valley, Inc. Store 38
- Quantity
- 2,840 4mL syringes
- Distribution
- Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
- Recall date
- February 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)