FDA Drug recall D-0997-2019
Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe
- FDA Drug
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe by Avella Of Deer Valley Store 38, citing 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….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0997-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-08 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avella Of Deer Valley Store 38 |
| Distribution | AL, AZ, CA, CO, FL, ID, MI, MN, NC, NJ, OR, PA, TX |
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.
Reason
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.
Identifiers
| code_info | 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/…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0997-2019%22
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