CLASS II Drug recall · Reported 3 Apr 2024 · FDA Enforcement Report
PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled
SCA Pharmaceuticals is recalling PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), distributed nationwide in the US. The recall was initiated on 9 Nov 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-0416-2024
- FDA event ID
- 93456
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Nov 2023
- FDA classified
- 22 Mar 2024
- Reported
- 3 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 9 Nov 2023 | Recall initiated by company | |
| 22 Mar 2024 | Classified by FDA | +134 days |
| 3 Apr 2024 | Published in enforcement report | +12 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 HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
Where it was distributed
Nationwide in the USA
Questions about this recall
Is PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection, (Concentration = 100 mcg/mL) recalled?
Yes. SCA Pharmaceuticals recalled PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection, (Concentration = 100 mcg/mL) on 9 Nov 2023. The recall is Class II and its status is Terminated. Recall number D-0416-2024.
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
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 SCA Pharmaceuticals
All 166| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | fentaNYL 200 mcg/, Bupivacaine HCl recalled by SCA Pharmaceuticals | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | fentaNYL 2,500 mcg/ Injection (Concentration = 50 mcg/mL) recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | SUCcinylcholine Chloride 200 mg/ Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | HYDROmorphone HCl 30 mg/ in 9% Sodium Chloride Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |