B. Braun Recalls TrophAmine Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection) units due to visible particulate matter found in reserve samples.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container. The recall affects 17,544 units of Lot# J3A028, which has an expiration date of 07/14.
The recall was initiated because visible particulate matter was found in reserve sample units of the product. The agency has classified this recall as Class I.
The affected units were distributed nationwide, as well as in Puerto Rico and Spain. Consumers and healthcare providers should stop using the affected product and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- Product
- TrophAmine (10% Amino Acid Injection), 500 mL Container, Rx Only, Catalog No. S9341-SS, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-9341-55
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 17,544
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# J3A028
- Exp 07/14
Distribution
Part of a larger recall action
This product is one of 12 recalled by B. Braun Medical Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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