oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag, Rx Only, SCA Pharmaceuticals 8821 Knoedl ...

FDA Recall #D-0065-2018 — Class II — October 19, 2017

Recall #D-0065-2018 Date: October 19, 2017 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

SCA Pharmaceuticals, LLC — Little Rock, AR

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

450 bags

Distribution

Nationwide in the United States

Code Information

Lot: 20170912@13 BUD: 10/22/2017

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated