Pharmalucence Sestamibi Injection Kits Recalled for Particulate Matter
Pharmalucence, Inc. is recalling Technetium Tc 99m Sestamibi Injection kits due to the presence of particulate matter found in retained samples.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Pharmalucence, Inc. is recalling Pharmalucence Kits for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. The recall involves 17,260 vials from Lot 280011, which expired in August 2013. The product is available in five-vial and thirty-vial kits and is prescribed for intravenous use and reconstitution.
The recall was initiated because particulate matter was found in retained samples of the product. The agency has classified this as a Class III recall, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide as well as in the Bahamas, Barbados, Bermuda, and Japan. Healthcare providers and patients who have this specific lot of the product should stop using it and contact Pharmalucence, Inc. for further instructions.
The recalled product
- Product
- Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc.,
- Manufacturer
- Pharmalucence, Inc.
- Category
- Drug — Radiopharmaceutical
- Hazard
- Affected units
- 17,260
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 (2)
- Lot 280011
- Exp 08/13
Distribution
Distributed nationwide across the United States.
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