Agency classClass IIOur severity:Severe FDA (Drugs)·D-1665-2012·Announced 2012-09-05

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.

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. 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
Hazard: sterility-loss
infection-risk
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.

Same brand · MULTIHANCE

Low
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