PlainRecalls
FDA Drug Moderate Class II Terminated

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

Reported: January 13, 2021 Initiated: December 17, 2020 #D-0209-2021

Product Description

Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016

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

Frequently Asked Questions

What product was recalled?
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016. Recalled by SCA Pharmaceuticals. Units affected: 116 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-0209-2021.