Recalls / Class II
Class IID-0198-2021
Product
labetalol HCl 20 mg/4 mL, Injection for Intravenous Use (5mg/mL), Rx Only, 4 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004070028
- Affected lot / code info
- Lot # 1220022969, BUD 3/1/2021; 1220023002, BUD 3/2/2021; 1220023045, BUD 3/2/2021; 1220023081, BUD 3/2/2021; 1220023130, BUD 3/6/2021; 1220023229, BUD 3/9/2021; 1220023287, BUD 3/12/2021 & 1220023335, BUD 3/22/2021.
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
- 9,057 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-0198-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.