CLASS II Drug recall · Reported 11 Jul 2018 · FDA Enforcement Report
Phenylephrine HCL 50 mg in 9% Sodium Chloride Bag recalled
SCA Pharmaceuticals is recalling Phenylephrine HCL 50 mg in 9% Sodium Chloride Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, distributed nationwide in the US. The recall was initiated on 14 Jun 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-0904-2018
- FDA event ID
- 80303
- Recalling firm
- SCA Pharmaceuticals, Windsor, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jun 2018
- FDA classified
- 2 Jul 2018
- Reported
- 11 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Cold & Cough Medicine
Timeline
| 14 Jun 2018 | Recall initiated by company | |
| 2 Jul 2018 | Classified by FDA | +18 days |
| 11 Jul 2018 | 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: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
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 50 mg in 0.9% Sodium Chloride 250 mL Bag (200 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
Where it was distributed
Product was distributed throughout the United States.
Questions about this recall
Is Phenylephrine HCL 50 mg in 9% Sodium Chloride Bag (200 mcg/mL), SCA Pharmaceuticals, LLC recalled?
Yes. SCA Pharmaceuticals recalled Phenylephrine HCL 50 mg in 9% Sodium Chloride Bag (200 mcg/mL), SCA Pharmaceuticals, LLC on 14 Jun 2018. The recall is Class II and its status is Terminated. Recall number D-0904-2018.
Why was it recalled?
Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Which lots are affected?
Lot # 20180329@2, Exp 06/27/2018
Where was it sold?
Product was distributed throughout the United States.
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 | PHENYLephrine HCl 500 mcg/ in 9% Sodium Chloride Injection 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 |