Recalls / Class II
Class IID-0210-2021
Product
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
- Affected lot / code info
- Lot # 1220022958, BUD 1/20/2021; 1220023013, BUD 1/18/2021; 1220023035, BUD 1/19/2021; 1220023036, BUD 1/21/2021; 1220023059, BUD 1/21/2021; 1220023094, BUD 1/25/2021; 1220023167, BUD 1/26/2021; 1220023208, BUD 1/27/2021; 1220023291, BUD 1/31/2021; 1220023359, BUD 2/2/2021; 1220023401, BUD 2/2/2021 & 1220023473, BUD 2/4/2021.
Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 14,580 syringes
- Distribution pattern
- Product was distributed to hospitals nationwide.
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2021-01-07
- Posted by FDA
- 2021-01-13
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0210-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.