Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product description
5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, The Compounding Pharmacy of America, Knoxville, TN
Lot numbers, UPCs & expiration codes
All lots distributed between November 2014 and May 2015; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015
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-1432-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 2, 2015
- FDA report date
- Sep 23, 2015
- Quantity
- 351 ML total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Compounding Pharmacy of America
Original FDA data
Every field from FDA enforcement report D-1432-2015, 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; 02232015@75, 5/24/2015; 03042015@22, 6/2/2015; 03172015@44, 6/15/2015; 03192015@21, 6/17/2015; 03232015@61, 6/21/2015; 03272015@49, 6/25/2015; 04132015@50, 7/12/2015; 04132015@54, 7/12/201; 04152015@35, 7/14/2015; 04162015@12, 7/15/2015; 04222015@39, 7/21/2015, 04242015@3, 7/23/2015; 05012015@53, 7/30/2015; 05062015@20, 8/4/2015; 05052015@105, 8/3/2015
- Postal code
- 37919-4068
- Report date
- Sep 23, 2015
- Product type
- Drugs
- Recall number
- D-1432-2015
- Classification
- Class II
- Recalling firm
- The Compounding Pharmacy of America
- Product quantity
- 351 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
- 5-Methy Tetrahydrofolate 5 mg/ml Injectable, Sterile-Multi-Dose Vial, 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