CLASS II Drug recall · Reported 20 Feb 2019 · FDA Enforcement Report
Labetalol 20mg, HCL, USP Injectable Solution, 20mg recalled
Avella of Deer Valley Inc. Store 38 is recalling Labetalol 20mg, HCL, USP Injectable Solution, 20mg/ (5 mg per mL) single use syringe, distributed in 13 states. The recall was initiated on 8 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0997-2019
- FDA event ID
- 82102
- Recalling firm
- Avella of Deer Valley Inc. Store 38, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Feb 2019
- FDA classified
- 12 Mar 2019
- Reported
- 20 Feb 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Feb 2019 | Recall initiated by company | |
| 20 Feb 2019 | Published in enforcement report | +12 days |
| 12 Mar 2019 | Classified by FDA | +20 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
AlabamaArizonaCaliforniaColoradoFloridaIdahoMichiganMinnesotaNorth CarolinaNew JerseyOregonPennsylvaniaTexas
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
Distribution to 13 states: Alabama, Arizona, California, Colorado, Florida, Idaho, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Texas.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 82102This product is part of a recall event; the main page for the event is MAGnesium 2 gm sulfate, added to NS, Sterile single use recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | MAGnesium 2 gm sulfate, added to NS, Sterile single use recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states | |
| CLASS II | MAGnesium 1gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states | |
| CLASS II | MAGnesium 2gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
More recalls from Avella of Deer Valley Inc. Store 38
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Povidone Iodine, 5% Ophthalmic Solution per droptainer recalled | Avella of Deer Valley Inc. Store 38 | Sterility | Nationwide |
| Drug | CLASS II | Bevacizumab 2.5 mg recalled by Avella of Deer Valley, Inc. | Avella of Deer Valley Inc. Store 38 | Sterility | Nationwide |
| Drug | CLASS II | MAGnesium 2gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | MAGnesium 1gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
| Drug | CLASS II | MAGnesium 2 gm sulfate, added to NS, Sterile single use recalled | Avella of Deer Valley Inc. Store 38 | Other | 13 states |
Other Labetalol recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Labetalol Hydrochloride Injection, USP, 20 mg recalled by PfizerLabetalol Hydrochloride | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | labetalol HCl 20 mg/ Injection, (Concentration=5 mg/mL) fill Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Labetalol Hydrochloride Tablets, USP, 100 mg recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Labetalol HCl Injection, USP, 20 mg/ (5 mg/mL) recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |