Recalls / Class II
Class IID-1004-2017
Product
PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 mg per mL), Total Volume 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205 (877) 550-5059; NDC: 70004-0810-32.
- Affected lot / code info
- Lot: 20170710@3, BUD: 10/8/2017
Why it was recalled
Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have 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
- 2 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2017-07-14
- FDA classified
- 2017-07-25
- Posted by FDA
- 2017-08-02
- Terminated
- 2019-10-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1004-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.