Recalls / Class II
Class IID-1009-2017
Product
fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40
- Affected lot / code info
- Lots: 20170502@18 BUD: 7/31/2017; 20170502@39 BUD: 7/31/2017; 20170502@62 BUD: 7/31/2017; 20170503@22 BUD: 8/1/2017; 20170503@4 BUD: 8/1/2017; 20170503@54 BUD: 8/1/2017; 20170504@10 BUD: 8/2/2017; 20170505@15 BUD: 8/3/2017; 20170506@23 BUD: 8/4/2017
Why it was recalled
Lack of Assurance of Sterility; product has the potential to leak.
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-14
- FDA classified
- 2017-07-26
- Posted by FDA
- 2017-08-02
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1009-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.