D-0064-2018 Class II Terminated
FDA drug recall D-0064-2018 was initiated by SCA Pharmaceuticals, LLC on October 19, 2017 and is designated Class II. Reason for recall: Lack Of Assurance Of Sterility. The recall status is terminated (terminated May 1, 2019). Affected quantity: a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag.
Recall Details
- Product Type
- Drugs
- Report Date
- November 8, 2017
- Initiation Date
- October 19, 2017
- Termination Date
- May 1, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 60 bag inside rigid translucent plastic case (CADD) b) 238 bag
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.
Distribution Pattern
Nationwide in the United States
Code Information
Lots: a) 20170905@24 BUD: 12/04/2017 b) 20170901@25 BUD: 11/30/2017