November 2013 FDA Recall Drug by Tower Pharmacy And Compounding
D-384-2014 - Microbial Contamination of Non Sterile Products
This Class II drug recall was voluntarily initiated by Tower Pharmacy And Compounding on November 16, 2013 for the product Drug. The FDA reported the reason for recall as microbial contamination of non sterile products. The product was distributed in CA and the recall is currently terminated.
Recall Number: D-384-2014
Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.
11-16-2013
01-01-2014
2 Bottles
Recall Profile & Regulatory Data
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.
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.
Tower Pharmacy and Compounding
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.
CA
01-13-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Phenylephrine Nasal 1% Spray, 480 mL bottles, For Office Use, Tower Pharmacy, 26732 Crown Valley Pkwy, Suite 101, Mission Viejo, CA 92691
Batch or Lot Expiration Information
Lot# 13603, Exp 12/13
