Bracco Recalls Multihance Injection Due to Sterility Concerns
Bracco Diagnostics is recalling 4,870 vials of Multihance injection because aluminum crimp caps may displace during use, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility loss in an IV product) map to a score of 4 (Severe), as Class I is required for a score of 5.
Plain-English summary
Bracco Diagnostics Inc. is recalling 4,870 vials of Multihance (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package. The affected products are 50 mL and 100 mL single-dose vials intended for intravenous use. The recall is due to a lack of assurance of sterility caused by the displacement of the aluminum crimp cap during product usage.
The recall covers specific lots distributed nationwide. Lot 9J37457 and 9J44058 (50 mL vials) have an expiration date of 10/12. Lot 9I28973 (100 mL vials) has an expiration date of 09/12. The products were manufactured by Nycomed GmbH in Germany for Bracco Diagnostics Inc.
Healthcare providers and patients should stop using the affected vials and contact Bracco Diagnostics for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MULTIHANCE (GADOBENATE DIMEGLUMINE)
- Brand
- MULTIHANCE
- Manufacturer
- Bracco Diagnostics Inc
- Category
- Drug — Injectable Contrast Agent
- Affected units
- 4,870
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 (5)
- Lot #: a) 9J37457
- 9J44058
- Exp 10/12
- b) 9I28973
- Exp 09/12
Distribution
Distributed nationwide across the United States.
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