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
17 Alpha Hydroxyprogesterone Caproate 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-286-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 17, 2013
- FDA report date
- May 1, 2013
- Quantity
- 4 vials (5 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-286-2013, 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-286-2013
- Classification
- Class II
- Recalling firm
- Axium Healthcare Pharmacy dba Balanced Solutions Compounding
- Product quantity
- 4 vials (5 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
- 17 Alpha Hydroxyprogesterone Caproate 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