Recalls / Class II
Class IID-1040-2018
Product
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.
- Brand name
- Kit For The Preparation Of Technetium Tc 99m Medronate
- Generic name
- Tc 99m Medronate
- Active ingredient
- Technetium Tc-99m Medronate
- Route
- Intravenous
- NDC
- 45567-0040
- FDA application
- NDA018124
- Affected lot / code info
- Lot 4223
Why it was recalled
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Recalling firm
- Firm
- Pharmalucence, Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 29 Dunham Rd, N/A, Billerica, Massachusetts 01821-5729
Distribution
- Quantity
- 95 kits
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2018-06-06
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2019-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1040-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.