Billerica, MA, United States
Pharmalucence, Inc. recalls
2 recalls recorded since 2018, most recently on 6 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 6 June 2018
- Terminated
- 11 March 2019
- Reason
- Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1040-2018
- 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 0
Terminated Class II Drugs
- Recall started
- 10 April 2018
- Terminated
- 31 October 2018
- Reason
- Failed Stability Specifications
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0815-2018
- Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.