D-0068-2018 Class II Terminated
FDA drug recall D-0068-2018 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: 487 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
- 487 syringes
Product Description
ROCuronium Bromide 10 mg per mL, 5 mL Fill in single dose syringe, (50 mg / 5 mL Total Dose) Rx Only SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-850-09
Reason for Recall
Lack Of Assurance Of Sterility.
Distribution Pattern
Nationwide in the United States
Code Information
Lot: 20171004@4 BUD: 01/09/2018