FDA recall D-1231-2015

Abrams Royal Pharmacy II, LLC · Class III · drug

Product

CORTISOL-MC, 10mg CAP, packaged in 30 and 90 count bottles, Rx Only, ABRAMS ROYAL pharmacy II, 4909 W Park Blvd, Suite 177, Plano, TX 75093 --- NDC 88888-0043-31

Reason for recall

Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.

Distribution

United States including: Texas

Key facts

Status
Terminated
Initiation date
2015-06-23
Report date
2015-07-15
Termination date
2017-01-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1231-2015