Why it was recalled
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Product description
Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Lot numbers, UPCs & expiration codes
Lot 4223
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-1040-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 95 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pharmalucence, Inc.
Original FDA data
Every field from FDA enforcement report D-1040-2018, exactly as published.
Show all FDA fields
- City
- Billerica
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 80428
- Address
- 29 Dunham Rd
- Code information
- Lot 4223
- Postal code
- 01821-5729
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1040-2018
- Classification
- Class II
- Recalling firm
- Pharmalucence, Inc.
- Product quantity
- 95 kits
- Termination date
- Mar 11, 2019
- Reason for recall
- Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jun 6, 2018
- Initial firm notification
- Telephone
- Center classification date
- Aug 3, 2018