PlainRecalls
FDA Drug Low Class III Terminated

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

Reported: January 13, 2021 Initiated: December 17, 2020 #D-0201-2021

Product Description

Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025

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

Frequently Asked Questions

What product was recalled?
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025. Recalled by SCA Pharmaceuticals. Units affected: 751 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: Low. Recall number: D-0201-2021.