Recalls / Class II
Class IID-0200-2021
Product
Lidocaine HCl 2% 5 mL, 20 mg/mL, Rx Only, 5 mL syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072309
- Affected lot / code info
- Lot # 1220023034, BUD 1/19/2021; 1220023088, BUD 1/24/2021; 1220023112, BUD 1/25/2021; 1220023288, BUD 1/31/2021; 1220023323, BUD 2/2/2021; 1220023539, BUD 2/8/2021 & 1220023613, BUD 2/10/2021.
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
- 7,275 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-0200-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.