Why it was recalled
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Product description
Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
CO, GA, MI, and Puerto Rico
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-280-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 17, 2013
- FDA report date
- May 1, 2013
- Quantity
- 10 vials (30 mL each)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Original FDA data
Every field from FDA enforcement report D-280-2013, exactly as published.
Show all FDA fields
- City
- Lake Mary
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 64957
- Address
- 550 Technology Park Ste 1008
- Code information
- All Lots
- Postal code
- 32746-7131
- Report date
- May 1, 2013
- Product type
- Drugs
- Recall number
- D-280-2013
- Classification
- Class II
- Recalling firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Product quantity
- 10 vials (30 mL each)
- Termination date
- Apr 19, 2017
- Reason for recall
- Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Comprehensive injection #4 - SS varied injectable Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
- Distribution pattern
- CO, GA, MI, and Puerto Rico
- Recall initiation date
- Apr 17, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Apr 23, 2013