FDA recall D-0065-2018

SCA Pharmaceuticals, LLC · Class II · drug

Product

oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205, NDC 70004-0086-44

Reason for recall

Lack Of Assurance Of Sterility.

Distribution

Nationwide in the United States

Key facts

Status
Terminated
Initiation date
2017-10-19
Report date
2017-11-08
Termination date
2019-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0065-2018