Pharmalucence Recalls Technetium TC 99M Medronate Kits Due to Sterility Breach
Pharmalucence, Inc. is recalling 95 kits of Technetium TC 99M Medronate due to a reported breach of sterility. The affected product is distributed nationwide.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of infection associated with a sterility breach in an injectable drug.
Plain-English summary
Pharmalucence, Inc. is recalling 95 kits of Kit for the Preparation of Technetium TC 99M Medronate (TC 99M Medronate). The product is available in 5-count and 30-count boxes and is manufactured in Billerica, MA. The recall is limited to Lot 4223.
The recall was initiated because of a reported breach of sterility in the product. This lack of assurance of sterility poses a potential risk to patients who receive the medication.
The affected kits were distributed nationwide. This is a prescription-only product intended for intravenous use. Healthcare providers and patients should stop using the affected lots and contact the manufacturer or their local FDA office for further instructions.
The recalled product
- Product
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE (TC 99M MEDRONATE)
- Brand
- KIT FOR THE PREPARATION OF TECHNETIUM TC 99M MEDRONATE
- Manufacturer
- Pharmalucence, Inc.
- Category
- Drug — Radiopharmaceutical
- Affected units
- 95
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)
- Lot 4223
Distribution
Distributed nationwide across the United States.
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