Pharmalucence Recalls Technetium TC 99M Mebrofenin Kits for Stability Failures
Pharmalucence, Inc. is recalling Technetium TC 99M Mebrofenin kits nationwide because they failed stability specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Pharmalucence, Inc. is recalling specific lots of Kit for the Preparation of Technetium TC 99M Mebrofenin. The recall involves 157 units of the 5-count package (NDC 45567-0455-1) and 464 units of the 30-count package (NDC 45567-0455-2). These products were distributed nationwide in the United States.
The recall was initiated because the affected products failed stability specifications. The specific lots involved are identified by Part Numbers MEM05 and MEB30, both with an expiry date of 12/2018. The kits are manufactured by Pharmalucence, Inc., located in Billerica, MA.
Healthcare providers and facilities that have received these products should stop using them and contact Pharmalucence, Inc. for further instructions regarding the return or disposal of the recalled items.
The recalled product
- Product
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN)
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEBROFENIN
- Manufacturer
- Pharmalucence, Inc.
- Category
- Drug — Radiopharmaceutical
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part Number MEM05 and MEB30 both with expiry date 12/2018
Distribution
Distributed nationwide across the United States.
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