CLASS II Drug recall · Reported 19 Jul 2017 · FDA Enforcement Report
Potassium PHOSphate added to 9% Sodium Chloride 15 mMol recalled
SCA Pharmaceuticals is recalling Potassium PHOSphate added to 9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate, distributed in Louisiana, New York, Pennsylvania, Wisconsin. The recall was initiated on 21 Jun 2017 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-0978-2017
- FDA event ID
- 77600
- Recalling firm
- SCA Pharmaceuticals, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2017
- FDA classified
- 13 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 21 Jun 2017 | Recall initiated by company | |
| 13 Jul 2017 | Classified by FDA | +22 days |
| 19 Jul 2017 | 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 sterility assurance
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
Potassium PHOSphate added to 250 mL 0.9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate Volume 255 mL, Rx only, SCA Pharmaceuticals, Little Rock, AR 72205, NDC 70004-0841-32
Where it was distributed
LA, PA, NY, WI
Questions about this recall
Is Potassium PHOSphate added to 9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate recalled?
Yes. SCA Pharmaceuticals recalled Potassium PHOSphate added to 9% Sodium Chloride 15 mMol (22 mEq K+) Total Approximate on 21 Jun 2017. The recall is Class II and its status is Terminated. Recall number D-0978-2017.
Why was it recalled?
Lack of sterility assurance
Which lots are affected?
Lot #: 20170602@29, Exp 7/17/2017
Where was it sold?
LA, PA, NY, WI
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 |