Drug Recall: Draximage MAA Injectable Kit Due to Sterility Failure
Jubilant Draximage Inc. is recalling Draximage MAA, an injectable diagnostic drug kit, due to failed endotoxin testing. The recall affects 519 cartons distributed nationwide (Lot 1H005, expiration November 30, 2023).
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of an injectable drug due to documented failure to meet sterility standards (endotoxin testing out-of-specification). This qualifies as a risk-of-harm product with a confirmed quality defect, though no illnesses or injuries are reported in the recall notice.
Plain-English summary
Jubilant Draximage Inc. is recalling Draximage MAA (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated), an injectable diagnostic imaging preparation. The recall affects 519 cartons distributed nationwide (Lot 1H005, expiration date November 30, 2023, NDC 65174-270-30).
The recall was initiated due to out-of-specification endotoxin test results, indicating that the product does not meet the required standards for sterility assurance. Healthcare providers who have this product should immediately quarantine it and discontinue use in patient care.
Patients who may have received this preparation should consult with their healthcare provider if they have any concerns about recent diagnostic procedures.
The recalled product
- Product
- DRAXIMAGE MAA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M ALBUMIN AGGREGATED)
- Brand
- DRAXIMAGE MAA
- Manufacturer
- Jubilant Draximage Inc
- Category
- Drug — Radiopharmaceutical
- Hazard
- endotoxin-contamination
- sterility-failure
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 (3)
- Lot # 1H005
- exp. date Nov 30
- 2023
Distribution
Distributed nationwide across the United States.
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