Recalls / Class II
Class IID-0815-2018
Product
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.
- Brand name
- Kit For The Preparation Of Technetium Tc 99m Mebrofenin
- Generic name
- Kit For The Preparation Of Technetium Tc 99m Mebrofenin
- Active ingredient
- Mebrofenin
- Route
- Intravenous
- NDC
- 45567-0455
- FDA application
- ANDA078242
- Affected lot / code info
- Part Number MEM05 and MEB30 both with expiry date 12/2018
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Pharmalucence, Inc.
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 29 Dunham Rd, Billerica, Massachusetts 01821-5729
Distribution
- Quantity
- 157 units (5 count) and 464 units (30 count)
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2018-04-10
- FDA classified
- 2018-05-15
- Posted by FDA
- 2018-05-23
- Terminated
- 2018-10-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0815-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.