FDA recall D-0555-2023

SCA Pharmaceuticals · Class III · drug

Product

Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44

Reason for recall

Subpotent Drug: Out of specification results for low potency was obtained.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2023-04-10
Report date: 2023-05-03
Termination date: 2023-09-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0555-2023