Why it was recalled
Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Product description
Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
Lot numbers, UPCs & expiration codes
Lot 74651-LG4973, Exp 12/4/13
Where it was sold
NC
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-1069-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2013
- FDA report date
- Oct 9, 2013
- Quantity
- 8 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Triangle Compounding
Original FDA data
Every field from FDA enforcement report D-1069-2013, exactly as published.
Show all FDA fields
- City
- Cary
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 66297
- Address
- 3700 Regency Pkwy Ste 140
- Code information
- Lot 74651-LG4973, Exp 12/4/13
- Postal code
- 27518-8696
- Report date
- Oct 9, 2013
- Product type
- Drugs
- Recall number
- D-1069-2013
- Classification
- Class II
- Recalling firm
- Triangle Compounding
- Product quantity
- 8 vials
- Termination date
- Apr 23, 2025
- Reason for recall
- Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518.
- Distribution pattern
- NC
- Recall initiation date
- Sep 6, 2013
- Initial firm notification
- Telephone
- Center classification date
- Sep 30, 2013