FDA recall D-0385-2016

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

Reason for recall

Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.

Distribution

AL, GA, TN, LA

Key facts

Status

Terminated

Initiation date

2015-06-22

Report date

2015-11-25

Termination date

2015-11-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Birmingham, AL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2016