Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN
Lot numbers, UPCs & expiration codes
All lots distributed between November 2014 and May 2015; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015
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-1764-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 307 ml total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-1764-2015, 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; 01082015@10, 7/7/2015; 12022014@44, 5/31/2015; 12192014@14, 6/17/2015; 01072015@22, 7/6/2015; 01262015@83, 7/25/2015; 02092015@12, 8/8/2015 02132015@5, 8/12/2015; 02202015@19, 8/19/2015; 02192015@24, 8/18/2015; 03022015@49, 8/29/2015; 03302015@1, 9/26/2015; 03312015@12, 9/27/2015; 04012015@63, 9/28/2015; 04162015@37, 10/13/2015; 05042015@37, 10/31/2015
- Postal code
- 37919-4068
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1764-2015
- Classification
- Class II
- Recalling firm
- The Compounding Pharmacy of America
- Product quantity
- 307 ml total
- 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
- Tri-Mix (17.7 mg/0.59 mg/6 mcg) Injectable, Sterile, Keep Frozen, 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