B. Braun Recalls 15% Amino Acids Injection Due to Particulate Matter
B. Braun Medical Inc. is recalling 15% Amino Acids Injection products due to visible particulate matter found in reserve sample units.
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 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
B. Braun Medical Inc. is recalling 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS. The recall involves 18,288 units of the sterile, single-dose container intended for intravenous use. The affected lots are J2J012 (Exp 01/14) and J3B002 (Exp 08/14).
The recall was initiated because visible particulate matter was found in reserve sample units. The product is distributed nationwide, in Puerto Rico, and in Spain.
Healthcare providers and pharmacies should stop using the affected products and contact B. Braun Medical Inc. for further instructions.
The recalled product
- Product
- 15% Amino Acids Injection PBP Glass, 1000 mL, Catalog No. S3200-SS, Pharmacy Bulk Package, Not For Direct Infusion, For Intravenous Use, Sterile, Single Dose Container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-3200-55
- Manufacturer
- B. Braun Medical Inc
- Category
- Drug — Injectable
- Hazard
- Affected units
- 18,288
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 (4)
- Lot# J2J012
- Exp 01/14
- J3B002
- Exp 08/14
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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