Recalls / Class II
Class IID-0066-2018
Product
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL Fill Volume in a Single Dose Syringe (1,000 mcg / 10 ml Total Dose), Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR, NDC 70004-0810-12
- Affected lot / code info
- Lot: 20170920@53 BUD: 12/19/2017
Why it was recalled
Lack Of Assurance Of Sterility.
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8821 Knoedl Ct, N/A, Little Rock, Arkansas 72205-4600
Distribution
- Quantity
- 1221 syringes
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2017-10-19
- FDA classified
- 2017-11-02
- Posted by FDA
- 2017-11-08
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0066-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.