CLASS II Drug recall · Reported 13 Jan 2021 · FDA Enforcement Report
PHENYLephrine HCl 1000 mcg/ in 0.9% Sodium Chloride, (100 mcg/mL) recalled
SCA Pharmaceuticals is recalling PHENYLephrine HCl 1000 mcg/ in 0.9% Sodium Chloride, (100 mcg/mL), distributed nationwide in the US. The recall was initiated on 17 Dec 2020 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-0204-2021
- FDA event ID
- 86990
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2020
- FDA classified
- 7 Jan 2021
- Reported
- 13 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 17 Dec 2020 | Recall initiated by company | |
| 7 Jan 2021 | Classified by FDA | +21 days |
| 13 Jan 2021 | 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 for a defective syringe cap, resulting in a non-integral unit
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 1000 mcg/10 mL in 0.9% Sodium Chloride, (100 mcg/mL) Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081012
Where it was distributed
Product was distributed to hospitals nationwide.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Which lots are affected?
Lot # 1220022957, BUD 1/20/2021; 1220022993, BUD 1/21/2021; 1220023020, BUD 1/14/2021; 1220023037, BUD 1/19/2021; 1220023038, BUD 1/20/2021; 1220023074, 1/24/2021; 1220023103, BUD 1/24/2021; 1220023160, BUD 1/26/2021; 1220023180, BUD 1/27/2021; 1220023183, BUD 1/27/2021; 1220023216, BUD 1/28/2021; 1220023267, BUD 2/1/2021; 1220023272, BUD 1/3/2021; 1220023344, BUD 2/10/2021; 1220023387, BUD 2/9/2021; 1220023475,BUD 2/4/2021; 1220023479, BUD 2/4/2021; 1220023564, BUD 2/9/2021; 1220023565, BUD 2/9/2021; 1220023587, BUD 2/10/2021 & 1220023624, BUD 2/11/2021.
Where was it sold?
Product was distributed to hospitals 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 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 86990This product is part of a recall event; the main page for the event is HYDROmorphone HCl 10mg/ in 0.9% Sodium Chloride Injection, CII recalled.
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 | PHENYLephrine HCl 500 mcg/ in 0.9% Sodium Chloride 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 0.9% Sodium Chloride recalled | SCA Pharmaceuticals | Sterility | Nationwide |
Other Phenylephrine recalls
All 122| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phenylephrine Hydrochloride Injectable Solution, 40mg recalled | Wells Pharma of Houston | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg recalled | Denver Solutions | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine HCl Injection, USP 100 mg/ (10 mg/mL) vials recalled | Provepharm | Particulate Matter | Nationwide |
| Drug | CLASS II | phenylephrine in 0.9% Sodium Chloride Inj, 1mg per (100 mcg/mL) recalled | Hikma Injectables USA | Sterility | Nationwide |
| Drug | CLASS I | Phenylephrine in 0.9% Sodium Chloride Injection recalled | Hikma Injectables USA | Labeling Errors | 5 states |