Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Lot numbers, UPCs & expiration codes
All lots distributed between November 2014 and May 2015; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015
Where it was sold
Nationwide
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-1745-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 510 pellets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-1745-2015, exactly as published.
Show all FDA fields
- City
- Knoxville
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 71371
- Address
- 6216 Highland Place Way Ste 101-A
- Code information
- All lots distributed between November 2014 and May 2015; 12122014@8, 6/10/2015; 12042014@47, 6/2/2015; 01122015@54, 7/11/2015; 04142015@82, 10/11/2015; 01072015@32, 7/6/2015; 01192015@17, 7/18/2015; 02042015@43, 8/3/2015; 02232015@35, 8/22/2015; 02272015@30, 8/26/2015; 02272015@19, 8/26/2015; 03162015@55, 9/12/2015; 03192015@23, 9/15/2015; 03192015@33, 9/15/2015; 04012015@55, 9/28/2015; 04072015@42, 10/4/2015, 04072015@6, 10/4/2015; 04102015@46, 10/7/2015; 04162015@56, 10/13/2015; 04282015@7, 10/25/2015, 04272015@59, 10/24/2015; 04302015@59, 10/27/2015
- Postal code
- 37919-4068
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1745-2015
- Classification
- Class II
- Recalling firm
- The Compounding Pharmacy of America
- Product quantity
- 510 pellets
- Termination date
- Feb 10, 2016
- Reason for recall
- Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Testosterone 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 2, 2015
- Initial firm notification
- Telephone
- Center classification date
- Sep 15, 2015