The Recall Desk
ModerateFDA (Drugs)·D-0997-2019·Announced 2019-02-20

Avella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates

Avella of Deer Valley, Inc. is recalling 2,840 syringes of Labetalol 20mg Injectable Solution because the 2D barcodes contain incorrect expiration dates.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the specific defect is a labeling error regarding expiration dates in the barcode, which falls under the 'Minor labeling errors' criterion for a Moderate severity score.

Plain-English summary

Avella of Deer Valley, Inc. Store 38 is recalling 2,840 4mL single-use syringes of Labetalol 20mg, HCL, USP Injectable Solution. The product was repackaged by Avella Specialty Pharmacy in Phoenix, Arizona, and distributed to 13 states including Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, and Texas.

The recall was initiated because the product labels contain a Two-Dimensional (2D) barcode that reveals batch-specific information, including the expiration date. The expiration date encoded within these 2D barcodes is incorrect and does not match the correct expiration date printed on the face of the label itself.

Healthcare providers and patients should check their inventory for the specific lot codes and expiration dates listed in the recall notice. If the product is found, it should be quarantined and returned to the distributor or the recalling firm.

The recalled product

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 Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (12)

  • 138-20182712@49
  • BUD 4/6/2019
  • 138-20182712@63
  • 138-20182712@89
  • 138-20182712@90
  • 138-20182712@93
  • 138-20183112@88
  • BUD 4/10/2019
  • 138-20183112@89
  • 138-20183112@91
  • 138-20190201@96
  • BUD 4/12/2019

Distribution

Distributed in 13 states:

Part of a larger recall action

This product is one of 4 recalled by Avella of Deer Valley, Inc. Store 38 under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →