D-0060-2018 Class II Terminated
FDA drug recall D-0060-2018 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: 128 syringes.
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
- 128 syringes
Product Description
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill in 30 mL single-dose syringe (Total Dose Hydromorphone 25 mg/25 mL) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR NDC 70004-0303-17
Reason for Recall
Lack Of Assurance Of Sterility.
Distribution Pattern
Nationwide in the United States
Code Information
Lot: 20170808@52 BUD: 11/06/2017