PlainRecalls
FDA Drug Moderate Class II Terminated

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

Reported: January 13, 2021 Initiated: December 17, 2020 #D-0186-2021

Product Description

Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006

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
1,930 syringes
Distribution
Product was distributed to hospitals nationwide.
Location
Windsor, CT

Frequently Asked Questions

What product was recalled?
Atropine Sulfate Injection, 0.8 mg/2 mL (0.4 mg/mL), 2 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004004006. Recalled by SCA Pharmaceuticals. Units affected: 1,930 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-0186-2021.