Recalls / Class III
Class IIID-0147-2021
Product
Fentanyl, 250 mcg/ 5mL, Injection for IV or IM use, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205
- Affected lot / code info
- Lot #: 1220021578, Exp 12/2/2020; 1220021732, Exp 12/9/2020; 1220022385, Exp 12/29/2020; 1220022582, Exp 1/6/2021
Why it was recalled
Subpotency: Out-of-specification stability test result for low potency was obtained.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 4,843 syringes
- Distribution pattern
- Product was distributed to three hospitals in MO & LA.
Timeline
- Recall initiated
- 2020-11-20
- FDA classified
- 2020-12-14
- Posted by FDA
- 2020-12-23
- Terminated
- 2021-06-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0147-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.