Why it was recalled
Presence of Particulate Matter; particulate found in retain samples
Product description
Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821
Lot numbers, UPCs & expiration codes
Lot 280011, Exp 08/13
Where it was sold
Nationwide & Bahamas, Barbados, Bermuda, Japan
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-808-2013
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 30, 2013
- FDA report date
- Jul 31, 2013
- Quantity
- 17,260 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmalucence, Inc.
Original FDA data
Every field from FDA enforcement report D-808-2013, exactly as published.
Show all FDA fields
- City
- Billerica
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 65244
- Address
- 29 Dunham Rd
- Code information
- Lot 280011, Exp 08/13
- Postal code
- 01821
- Report date
- Jul 31, 2013
- Product type
- Drugs
- Recall number
- D-808-2013
- Classification
- Class III
- Recalling firm
- Pharmalucence, Inc.
- Product quantity
- 17,260 vials
- Termination date
- Oct 17, 2013
- Reason for recall
- Presence of Particulate Matter; particulate found in retain samples
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821
- Distribution pattern
- Nationwide & Bahamas, Barbados, Bermuda, Japan
- Recall initiation date
- May 30, 2013
- Initial firm notification
- Letter
- Center classification date
- Jul 19, 2013