FDA Drug recall D-1271-2014
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dos…
- FDA Drug
- Class I
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class I recall of 6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dos… by B Braun Medical, citing presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1271-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
6.9% FreAmine HBC (Amino Acid Injection), partial fill container 750 mL in a 1000 mL container, Catalog No. S9350-58SS, Sterile, Single dose container, Rx Only, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-9350-55
Reason
Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.
Identifiers
| code_info | Lot# J2H002, Exp 06/14; J2S018, Exp 12/14 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1271-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.