CLASS II Drug recall · Reported 25 Jul 2018 · FDA Enforcement Report
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg recalled
Avella of Deer Valley, Inc. Store 38 is recalling PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) Volume: Single dose, distributed nationwide in the US. The recall was initiated on 12 Jun 2018 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-0962-2018
- FDA event ID
- 80307
- Recalling firm
- Avella of Deer Valley, Inc. Store 38, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jun 2018
- FDA classified
- 19 Jul 2018
- Reported
- 25 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 12 Jun 2018 | Recall initiated by company | |
| 19 Jul 2018 | Classified by FDA | +37 days |
| 25 Jul 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Potential leakage of bags.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
Where it was distributed
Nationwide in the USA
Questions about this recall
Is PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) Volume: Single dose recalled?
Yes. Avella of Deer Valley, Inc. Store 38 recalled PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) Volume: Single dose on 12 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-0962-2018.
Why was it recalled?
Lack of Assurance of Sterility: Potential leakage of bags.
Which lots are affected?
Lot #: 5/22/18 1012 495-89425P, BUD 7/21/2018; 6/5/18 0302 495-89425P, BUD 8/4/2018. .
Where was it sold?
Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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 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 | Sterility | 13 states |
| Drug | CLASS II | MAGnesium 1gm sulfate, added to D5W, Volume recalled | Avella of Deer Valley, Inc. Store 38 | Sterility | 13 states |
| Drug | CLASS II | Labetalol 20mg, HCL, USP Injectable Solution, 20mg recalled | Avella of Deer Valley, Inc. Store 38 | Packaging Defects | 13 states |