Recalls / Class II
Class IID-0872-2017
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
- Affected lot / code info
- LOT # 20170505@14, Use By: 08/03/17; 20170510@2, Use By: 08/08/17
Why it was recalled
Lack of assurance of sterility: Product bags leaking at seam.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 118 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-05-18
- FDA classified
- 2017-05-31
- Posted by FDA
- 2017-06-07
- Terminated
- 2018-03-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0872-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.