Drug 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
D-0385-2016
Product summary
- Event
- Event 72592
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,712 capsules
- Official record key
drug-enforcement:D-0385-2016
Official wording
Reason: Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
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
Distribution pattern: AL, GA, TN, LA
Derived failure modes
-
Unknown
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.