CLASS II Drug recall · Reported 29 Apr 2015 · FDA Enforcement Report
Droperidol injection, 2.5 mg/mL recalled by SCA Pharmaceuticals
SCA Pharmaceuticals is recalling Droperidol injection, 2.5 mg/mL, 5 mg Total Dose Fill Volume per syringe, distributed in Arkansas, Indiana, Minnesota, Missouri. The recall was initiated on 24 Feb 2015 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-0965-2015
- FDA event ID
- 70583
- Recalling firm
- SCA Pharmaceuticals, Little Rock, AR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Feb 2015
- FDA classified
- 22 Apr 2015
- Reported
- 29 Apr 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Feb 2015 | Recall initiated by company | |
| 22 Apr 2015 | Classified by FDA | +57 days |
| 29 Apr 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of particulate.
Product as listed by the FDA
Droperidol injection, 2.5 mg/mL, 5 mg Total Dose, 2 mL Fill Volume per syringe, packaged in 10-count syringes per heat sealed bag, RX only; Compounded for Office Use by SCA Pharmaceuticals, Little Rock, AR (877 ) 550-5059 Bar Code 88888-7720-16
Where it was distributed
IN, AR, MO, MN
Questions about this recall
Why was it recalled?
Presence of particulate.
Which lots are affected?
Lot: 20141223@20
Where was it sold?
IN, AR, MO, MN
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.
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 Droperidol recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Droperidol Injectable Sterile Solution, 0.625mg/mL recalled | Premier Pharmacy Labs | Sterility | Nationwide |