PlainRecalls
FDA Drug Moderate Class II Terminated

morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205

Reported: November 8, 2017 Initiated: October 19, 2017 #D-0064-2018

Product Description

morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205

Reason for Recall

Lack Of Assurance Of Sterility.

Details

Recalling Firm
SCA Pharmaceuticals, LLC
Units Affected
a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag
Distribution
Nationwide in the United States
Location
Little Rock, AR

Frequently Asked Questions

What product was recalled?
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total Volume 100 mL in Single Dose CADD Cassette (Total morphine Dose 100 mg per 100 mL) (NDC 70004-0100-63) b) Total Volume 50 mL in Single Dose Syringe (Total morphine Dose 50 mg / 50 mL) (NDC 70004-0100-22) Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205. Recalled by SCA Pharmaceuticals, LLC. Units affected: a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag.
Why was this product recalled?
Lack Of Assurance Of Sterility.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 8, 2017. Severity: Moderate. Recall number: D-0064-2018.