CLASS II Drug recall · Reported 8 Nov 2017 · FDA Enforcement Report
morphine sulfate 1 mg per mL recalled by SCA Pharmaceuticals
SCA Pharmaceuticals is recalling morphine sulfate 1 mg per mL in 9% Sodium Chloride a) Total Volume in Single Dose CADD, distributed nationwide in the US. The recall was initiated on 19 Oct 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-0064-2018
- FDA event ID
- 78320
- Recalling firm
- SCA Pharmaceuticals, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2017
- FDA classified
- 2 Nov 2017
- Reported
- 8 Nov 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 19 Oct 2017 | Recall initiated by company | |
| 2 Nov 2017 | Classified by FDA | +14 days |
| 8 Nov 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 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
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
Where it was distributed
Nationwide in the United States
Questions about this recall
Is morphine sulfate 1 mg per mL in 9% Sodium Chloride a) Total Volume in Single Dose CADD recalled?
Yes. SCA Pharmaceuticals recalled morphine sulfate 1 mg per mL in 9% Sodium Chloride a) Total Volume in Single Dose CADD on 19 Oct 2017. The recall is Class II and its status is Terminated. Recall number D-0064-2018.
Why was it recalled?
Lack Of Assurance Of Sterility.
Which lots are affected?
Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017
Where was it sold?
Nationwide in 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 |