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.
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 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.
See all 12 products in this recall →Related recalls
Same manufacturer · B. Braun Medical Inc
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · particulate matter
See all →- SevereACTHAR Gel Recalled for Presence of Glass and Stopper Particulate Matter
FDA (Drugs) · 2026-09-02
- CriticalAmerican Regent Recalls Papaverine Hydrochloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Nitroglycerin Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Multrys Trace Elements Injection Due to Particulate Matter
FDA (Drugs) · 2026-08-26