Baxter Healthcare Corp.: Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.; Presence of Particulate Matter: particulate matter identified as fibers and/or plastics

Agency Publication Date: September 18, 2014

Affected Products

Product: 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14

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 USA, NDC 0338-0553-18, Product Code 2B0043.

Lot #: P308650, Exp 10/14

Lot Numbers:

P308650

Product: Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.

Lot #: P309476, Exp 10/14

Lot Numbers:

P309476

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68728

Status: Resolved

Manufacturer: Baxter Healthcare Corp.

Manufactured In: United States

Units Affected: 3 products (a) 217,536 bags; b) 161,760 bags; 390,560 bags; 171,672 bags)

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14

Lot #: P308650, Exp 10/14

Lot Numbers:

P308650

Product: Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0703-41, Product Code 2B0822.

Lot #: P309476, Exp 10/14

Lot Numbers:

P309476