CLASS II Drug recall · Reported 11 Oct 2023 · FDA Enforcement Report
PHENYLephrine in 9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe recalled
Central Admixture Pharmacy Services is recalling PHENYLephrine in 9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe, distributed nationwide in the US. The recall was initiated on 21 Sep 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-0006-2024
- FDA event ID
- 93103
- Recalling firm
- Central Admixture Pharmacy Services, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2023
- FDA classified
- 4 Oct 2023
- Reported
- 11 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 21 Sep 2023 | Recall initiated by company | |
| 4 Oct 2023 | Classified by FDA | +13 days |
| 11 Oct 2023 | Published in enforcement report | +7 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 in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Is PHENYLephrine in 9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe recalled?
Yes. Central Admixture Pharmacy Services recalled PHENYLephrine in 9 sodium chloride, 800 mcg/, (80 mcg/mL) Syringe on 21 Sep 2023. The recall is Class II and its status is Terminated. Recall number D-0006-2024.
Why was it recalled?
Lack of assurance of sterility:
Which lots are affected?
Lot: 17-275323, 17-275345, Exp. 10/3/2023; 17-275642, 17-275643, 17-275671, Exp. 10/8/2023; 17-275675, 17-275677, Exp. 10/9/2023; 17-276188, Exp. 10/18/2023
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 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.