Recalls / Class II
Class IID-0187-2021
Product
Buffered Lidocaine HCl, 1%, 5 mL (10mg/mL) with Sodium Bicarbonate Injection for Local Anesthetic Use, 5 mL Single Dose Syringe, Rx Only SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004072509
- Affected lot / code info
- Lot # 1220023305, BUD 12/17/2020; 12200223400, BUD 12/19/2020; 1220023536, BUD 12/25/2020; 1220023608, BUD 12/27/2020; 1220023811, BUD 12/26/2020 & 1220023812, BUD 12/26/2020.
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
- 3,793 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-0187-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.