April 2018 FDA Recall Drug by Coast Quality Pharmacy Llc
D-0801-2018 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Coast Quality Pharmacy Llc on April 26, 2018 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in AL, CA, FL, MI, SC, TX and the recall is currently terminated.

Recall Number: D-0801-2018

Reason for Recall
Lack of Assurance of Sterility
Initiated
04-26-2018
Reported
05-16-2018
Quantity
52 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80005
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Coast Quality Pharmacy LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AL, CA, FL, MI, SC, TX
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-04-2020
Product Description About Product Description
Full technical description of the product.
Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

Batch or Lot Expiration Information

Lot# Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18