Why it was recalled
Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer 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
Lot numbers, UPCs & expiration codes
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
Where it was sold
AL, GA, TN, LA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0385-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 22, 2015
- FDA report date
- Nov 25, 2015
- Quantity
- 11,712 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Solutions Rx Pharmacy
Original FDA data
Every field from FDA enforcement report D-0385-2016, exactly as published.
Show all FDA fields
- City
- Birmingham
- State
- AL
- Status
- Terminated
- Country
- United States
- Event ID
- 72592
- Address
- 2705 4th Ave S
- 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
- Postal code
- 35233-2707
- Report date
- Nov 25, 2015
- Product type
- Drugs
- Recall number
- D-0385-2016
- Classification
- Class II
- Recalling firm
- Solutions Rx Pharmacy
- Product quantity
- 11,712 capsules
- Termination date
- Nov 27, 2015
- Reason for recall
- Penicillin Cross Contamination - Possible presence of penicillin in bulk budesonide powder used to compound prescription nasal rinse/nebulizer capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- AL, GA, TN, LA
- Recall initiation date
- Jun 22, 2015
- Initial firm notification
- Telephone
- Center classification date
- Nov 18, 2015