D-0385-2016 Class II Terminated
FDA drug recall D-0385-2016 was initiated by Solutions Rx Pharmacy on June 22, 2015 and is designated Class II. Reason for recall: Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules. The recall status is terminated (terminated November 27, 2015). Affected quantity: 11,712 capsules.
Recall Details
- Product Type
- Drugs
- Report Date
- November 25, 2015
- Initiation Date
- June 22, 2015
- Termination Date
- November 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,712 capsules
Product Description
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 Pattern
AL, GA, TN, LA
Code 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