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
Reported: January 13, 2021 Initiated: December 17, 2020 #D-0198-2021
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Details
- Recalling Firm
- SCA Pharmaceuticals
- Units Affected
- 9,057 syringes
- Distribution
- Product was distributed to hospitals nationwide.
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SCA Pharmaceuticals. Units affected: 9,057 syringes.
Why was this product recalled? ▼
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 13, 2021. Severity: Moderate. Recall number: D-0198-2021.
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