Baxter Healthcare Corp.: Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.; Presence of Particulate Matter: identified as cardboard.; Presence of Particulate Matter: identified as a cloth fiber.; Presence of Particulate Matter: identified as dried skin.

Agency Publication Date: May 23, 2016

Affected Products

Product: 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Lot #: P337857, Exp 07/31/16

Lot Numbers:

P337857

Lot #: P328997, Exp 01/31/2016

Lot Numbers:

P328997

Product: Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

Lot #: P339135, Exp 08/31/2017

Lot Numbers:

P339135

Product: CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.

Lot #: P333930, Exp 05/31/2017

Lot Numbers:

P333930

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73118

Status: Resolved

Manufacturer: Baxter Healthcare Corp.

Manufactured In: United States

Units Affected: 4 products (282,080 bags; 273,520 bags; 334,560 bags; 7,436 bags)

Were You Affected by This Recall?

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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.

Affected Products

Lot #: P337857, Exp 07/31/16

Lot Numbers:

P337857

Lot #: P328997, Exp 01/31/2016

Lot Numbers:

P328997

Product: Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

Lot #: P339135, Exp 08/31/2017

Lot Numbers:

P339135

Lot #: P333930, Exp 05/31/2017

Lot Numbers:

P333930