PlainRecalls
FDA Drug Moderate Class II Terminated

morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316

Reported: January 13, 2021 Initiated: December 17, 2020 #D-0202-2021

Product Description

morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316

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

Frequently Asked Questions

What product was recalled?
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316. Recalled by SCA Pharmaceuticals. Units affected: 50 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-0202-2021.