CLASS II Drug recall · Reported 7 Nov 2018 · FDA Enforcement Report
Phenylephrine 30 mg added to NS recalled by Avella of Deer Valley, Inc.
Avella of Deer Valley, Inc. Store 38 is recalling Phenylephrine 30 mg added to NS, distributed nationwide in the US. The recall was initiated on 19 Oct 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-0135-2019
- FDA event ID
- 81413
- Recalling firm
- Avella of Deer Valley, Inc. Store 38, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2018
- FDA classified
- 1 Nov 2018
- Reported
- 7 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 19 Oct 2018 | Recall initiated by company | |
| 1 Nov 2018 | Classified by FDA | +13 days |
| 7 Nov 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
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 30 mg added to NS 250 mL Bag, Rx only, Advanced Pharma, Inc. d/b/a Avella of Houston, and Avella of Deer Valley, Inc. #38
Where it was distributed
U.S.A. nationwide.
Questions about this recall
Is Phenylephrine 30 mg added to NS recalled?
Yes. Avella of Deer Valley, Inc. Store 38 recalled Phenylephrine 30 mg added to NS on 19 Oct 2018. The recall is Class II and its status is Terminated. Recall number D-0135-2019.
Why was it recalled?
Lack of assurance of sterility
Which lots are affected?
Lot# 138-20180409@55, Exp 11/18/2018
Where was it sold?
U.S.A. nationwide.
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 |