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.
Reported: May 23, 2018 Initiated: April 10, 2018 #D-0815-2018
Product Description
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.
Reason for Recall
Failed Stability Specifications
Details
- Recalling Firm
- Pharmalucence, Inc.
- Units Affected
- 157 units (5 count) and 464 units (30 count)
- Distribution
- US Nationwide
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmalucence, Inc.. Units affected: 157 units (5 count) and 464 units (30 count).
Why was this product recalled? ▼
Failed Stability Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 23, 2018. Severity: Moderate. Recall number: D-0815-2018.
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