Reported Feb 20, 2019 · Terminated
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella…
Avella of Deer Valley, Inc. Store 38
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avella of Deer Valley, Inc. Store 38 · 24416 N 19th Ave · Phoenix, AZ · 85085-1887
Is this the product you have?
- 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.
- Lot codes and dates
138-20182712@49BUD 4/6/2019138-20182712@63BUD 4/6/2019138-20182712@89BUD 4/6/2019138-20182712@90BUD 4/6/2019138-20182712@93BUD 4/6/2019138-20183112@88BUD 4/10/2019138-20183112@89BUD 4/10/2019138-20183112@91BUD 4/10/2019138-20190201@96BUD 4/12/2019
- Amount recalled
- 2,840 4mL syringes
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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