Recalls / Class II
Class IID-0965-2015
Product
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
- Affected lot / code info
- Lot: 20141223@20
Why it was recalled
Presence of particulate.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 421 syringes
- Distribution pattern
- IN, AR, MO, MN
Timeline
- Recall initiated
- 2015-02-24
- FDA classified
- 2015-04-22
- Posted by FDA
- 2015-04-29
- Terminated
- 2016-12-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0965-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.