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.
Reported: August 15, 2018 Initiated: June 6, 2018 #D-1040-2018
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.
Reason for Recall
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Details
- Recalling Firm
- Pharmalucence, Inc.
- Units Affected
- 95 kits
- Distribution
- Nationwide
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmalucence, Inc.. Units affected: 95 kits.
Why was this product recalled? ▼
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Moderate. Recall number: D-1040-2018.
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