Recalls / Class II
Class IID-0997-2019
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.
- Affected lot / 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 4/6/2019; 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
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.
Recalling firm
- Firm
- Avella of Deer Valley, Inc. Store 38
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 24416 N 19th Ave, N/A, Phoenix, Arizona 85085-1887
Distribution
- Quantity
- 2,840 4mL syringes
- Distribution pattern
- Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
Timeline
- Recall initiated
- 2019-02-08
- FDA classified
- 2019-03-12
- Posted by FDA
- 2019-02-20
- Terminated
- 2020-02-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0997-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.