June 2015 FDA Recall Drug by Solutions Rx Pharmacy
D-0385-2016 - Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.

This Class II drug recall was voluntarily initiated by Solutions Rx Pharmacy on June 22, 2015 for the product Drug. The FDA reported the reason for recall as penicillin cross contamination - possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.. The product was distributed in AL, GA, TN, LA and the recall is currently terminated.

Recall Number: D-0385-2016

Reason for Recall
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
Initiated
06-22-2015
Reported
11-25-2015
Quantity
11,712 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72592
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.
Solutions Rx Pharmacy
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.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
AL, GA, TN, LA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-27-2015
Product Description About Product Description
Full technical description of the product.
c-Budesonide 0.6MG capsules, 60-count bottle, NOT FOR ORAL USE-USE IN NASAL RINSE OR NEBULIZER, SOLUTIONS Rx PHARMACY, 2705 4TH AVENUE SOUTH, BIRMINGHAM, AL 35233

Batch or Lot Expiration Information

Lot# : 04-24-2015-D, Exp 05/31/15; 03-13-2015-C, 03-18-2015-F, 03-18-2015-G, 03-23-2015-C, 03-24-2015-C, 04-02-2015-G, 04-14-2015-F, 04-14-2015-G, 04-22-2015, 05-06-2015-B, 05-14-2015-D, 05-22-2015-F, 05-27-2015-C, 06-02-2015-E, 06-10-2015-J, Exp 06/16/15