CLASS II Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report
PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV recalled
Central Admixture Pharmacy Services is recalling PHENYLephrine added to 0.9% sodium chloride 50 mg/ (200mcg/mL), IV, distributed nationwide in the US. The recall was initiated on 17 Aug 2023 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-1128-2023
- FDA event ID
- 92898
- Recalling firm
- Central Admixture Pharmacy Services, Phoenix, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2023
- FDA classified
- 28 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 17 Aug 2023 | Recall initiated by company | |
| 28 Aug 2023 | Classified by FDA | +11 days |
| 6 Sep 2023 | Published in enforcement report | +9 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:Lack of validation data for sanitization cycles
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 added to 0.9% sodium chloride 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Which lots are affected?
Lot# 36-260038, Exp 10/3/2023. ;
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 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
31 other products · FDA event 92898This product is part of a recall event; the main page for the event is EPINEPHrine added to dextrose 5%, 4mg/ (16 mcg/mL), IV recalled.
More recalls from Central Admixture Pharmacy Services
All 347Other Phenylephrine Added To Chloride recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | PHENYLephrine added to 0.9% sodium chloride, 40 mg/* (160 mcg/mL) recalled | Central Admixture Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20mg/ (80 mcg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS II | phenylephrine 50 mg added to 0.9% sodium chloride recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |
| Drug | CLASS III | Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride recalled | New England Life Care | Other | Nationwide |
| Drug | CLASS II | PHENYLephrine added to 0.9% sodium chloride, 20 mg/* (80 mcg/mL) recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |