RecallRadar

FDA Drug recall D-1158-2014

Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only

On 2014-03-26 the FDA classified a Class I recall of Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only by Baxter Healthcare, citing presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1158-2014
ClassificationClass I
Statusterminated
Initiated2013-11-18
Published2014-03-26
Last updated2026-09-13 11:51 UTC
CompanyBaxter Healthcare
DistributionUS

Product

Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04.

Reason

Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose.

Identifiers

ndc0338-1142-03
ndc0338-1144-03
ndc0338-1113-04
ndc0338-1145-03
ndc0338-1115-04
ndc0338-1147-03
ndc0338-1123-04
ndc0338-1125-04
ndc0338-1148-03
ndc0338-0202-01
ndc0338-0202-06
ndc0338-0206-01
ndc0338-0206-04
ndc0338-0210-01
ndc0338-0210-06
ndc0338-0214-01
ndc0338-0214-04
ndc0338-7020-01
ndc0338-7020-06
ndc0338-7022-01
ndc0338-7022-06
ndc0338-7024-01
ndc0338-7024-04
ndc0338-7026-01
ndc0338-7026-06
ndc0338-7028-01
ndc0338-7028-04
ndc0338-7030-01
ndc0338-7030-06
ndc0338-7032-01
ndc0338-7032-04
ndc0338-7034-01
ndc0338-7034-06
ndc0338-7036-01
ndc0338-7036-04
code_infoLot#: P287045, Exp 6/2014

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-1158-2014%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.