Recalls / Class II
Class IID-1026-2017
Product
PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 ---- NDC# 70004-0811-59
- Affected lot / code info
- Lots: 20170503@29 BUD: 8/1/2017; 20170512@22 BUD: 8/10/2017; 20170509@64 BUD: 8/7/2017
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-1026-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.