US Drug Recall Register
Class II · Moderate risk Terminated Initiated Feb 8, 2019 (8 years ago)

Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was 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 was recalled

Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71.

Recalling firm
Avella of Deer Valley, Inc. Store 38
NDC code
42852-822-71
Origin
AZ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0997-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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