D-0997-2019 Class II Terminated
FDA drug recall D-0997-2019 was initiated by Avella of Deer Valley, Inc. Store 38 on February 8, 2019 and is designated Class II. Reason for recall: 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, inc… The recall status is terminated (terminated February 25, 2020). Affected quantity: 2,840 4mL syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- February 20, 2019
- Initiation Date
- February 8, 2019
- Termination Date
- February 25, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,840 4mL syringes
Product Description
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 for Recall
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.
Distribution Pattern
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Code Information
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