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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug

B. Braun Medical Inc: Presence of Particulate Matter: B. Braun Medical Inc. is recalling several injectable products due to visible particulate matter found in reserve sample units.

Agency Publication Date: April 25, 2014
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Affected Products

Product: Cefoxitin for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog No. 3123-11, For IV Use Only, Single Use, Sterile, Rx Only, B Braun Medical Inc, Irvine CA 92614-5895, NDC 0264-3123-11

Lot# H3E507, Exp 11/14

Lot Numbers:
H3E507
Product: 0.9 % Sodium Chloride Injection USP in PAB 50 mL partial fill in 100 mL PAB Container, Catalog No. S8004-5384, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1800-31

Lot# J2P912, Exp 02/14

Lot Numbers:
J2P912
Product: Ceftriaxone for Injection and Dextrose Injection, 1 g in Duplex, 50 mL Container, Catalog Number 3153-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895

Lot# H3B702, Exp 02/15

Lot Numbers:
H3B702
Product: Cefepime for Injections USP and Dextrose Injection USP, 1 g in Duplex, 50 mL Container, Catalog Number 3193-11, For IV Use Only, Single Dose, Sterile, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3193-11

Lot# H2L712, Exp 09/14

Lot Numbers:
H2L712
Product: Cefazolin for Injection USP and Dextrose Injections USP, 1 g in Duplex, 50 mL Container, Catalog Number 3103-11, For IV Use Only, Sterile, Single Dose, Rx Only, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-3103-11

Lot# H2S725, H2S726, Exp 07/14; H3D724, Exp 11/14; H3E724, Exp 12/14; Lot# H3H507, Exp 01/15

Lot Numbers:
H2S725
H3H507
Product: Cefazolin for Injection USP and Dextrose Injection USP, 2 g in Duplex, 50 mL Container, Catalog Number 3105-11, Rx Only, B Braun Medical Inc., Irvine CA 92614, NDC 0264-3105-11

Lot# H2S723, Exp 07/14; H3H711, Exp 01/15

Lot Numbers:
H2S723
Product: 0.9 % Sodium Chloride Injection USP, 1000 mL, Catalog No. S4000-SS, Rx Only, Sterile, Single Dose Container, B Braun Medical Inc., Irvine, CA 92614-5895, NDC 0264-4000-55

Lot# J0B003, Exp 02/14

Lot Numbers:
J0B003
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

Lot# J2H002, Exp 06/14; J2S018, Exp 12/14

Lot Numbers:
J2H002
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

Lot# J2J012, Exp 01/14; J3B002, Exp 08/14

Lot Numbers:
J2J012
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

Lot# J3A028, Exp 07/14

Lot Numbers:
J3A028
Product: ProcalAmine (3% Amino Acid and 3% Glycerin Injection with Electrolytes) 1000 mL Container, Rx Only, Catalog No. S9050, Sterile, Single Dose Container, B Braun Medical Inc., Irvine CA 92614-5895, NDC 0264-1915-07

Lot# J2K023, Exp 02/14

Lot Numbers:
J2K023
Product: Hyperlyte CR (Multi-Electrolyte Concentrate), 20 mL/dose, 250 mL Container, Catalog No. S9432, Rx Only, Sterile, B Braun Medical Inc., Irvine CA 92614-5895, In Canada Dist by: B Braun Medical Inc., Scarborough, Ontario M1H 2W4, NDC 0264-1943-20, Canada DIN 01924311

Lot# J3B007, Exp 08/14

Lot Numbers:
J3B007

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 66913
Status: Resolved
Manufacturer: B. Braun Medical Inc
Manufactured In: United States
Units Affected: 12 products (22,584 units; 53,592 units; 32,376 units; 22,248 units; 136,392 units; 42,576 units; 1302 units; 4614 units; 18,288 units; 17,544 units; 18,090 units; 5,592 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.