June 2015 FDA Recall Drug by Abrams Royal Pharmacy Ii, Llc
D-1231-2015 - Failed Content Uniformity Specifications
This Class III drug recall was voluntarily initiated by Abrams Royal Pharmacy Ii, Llc on June 23, 2015 for the product Drug. The FDA reported the reason for recall as failed content uniformity specifications. The product was distributed in United States including: Texas and the recall is currently terminated.
Recall Number: D-1231-2015
Failed Content Uniformity Specifications: Failed Uniformity of Dosage Units specifications.
06-23-2015
07-15-2015
30 count: 5 Bottles; 90 count: 2 Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Abrams Royal Pharmacy II, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
United States including: Texas
01-13-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 04012015@45, Expiry: 09/28/2015
