D-0875-2017 Class II Terminated
FDA drug recall D-0875-2017 was initiated by SCA Pharmaceuticals on May 18, 2017 and is designated Class II. Reason for recall: Lack of assurance of sterility: Product bags leaking at seam. The recall status is terminated (terminated March 29, 2018). Affected quantity: 87 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- June 7, 2017
- Initiation Date
- May 18, 2017
- Termination Date
- March 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 87 bags
Product Description
HYDROmorphone HCL in 0.9% Sodium Chloride injectable, 0.2 mg per ml, Total Volume 100mL, Single Dose Container bag, (Total HYDROmorphone Dose 20 mg per 100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0300-55
Reason for Recall
Lack of assurance of sterility: Product bags leaking at seam.
Distribution Pattern
Nationwide in the USA
Code Information
LOT # 20170505@23, 20170505@28, Use By: 08/03/17