Drugs

Extension of Shelf Life Provided by Baxter Healthcare Corporation to Assist with IV Solution Shortages

Due to the ongoing critical shortage of IV solutions used in critical care, FDA is alerting health care professionals of extension of shelf life through which some of these products, manufactured by Baxter Healthcare Corporation, may be used beyond the manufacturer’s labeled expiration date. To help ensure patient safety, these products should have been — and should continue to be — stored as labeled.

FDA is not requiring or recommending that the identified product codes in the following TABLE 1 be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then it is expected that the product codes in these tables will be replaced and properly disposed of as soon as possible.

Health care professionals are instructed to squeeze the bags prior to use for verification of no leaks. If leaks are found the bags are not to be used.

Based on data provided by Baxter Healthcare Corporation and reviewed by FDA, the following extended shelf life is supported for only the product codes indicated in TABLE 1 below for the following products.

Please contact CDER Drug Shortage Staff at drugshortages@fda.hhs.gov  with questions regarding this table.

TABLE 1

CodeProduct DescriptionCurrent Shelf Life (month/year)Extended Shelf Life(month/year)End-User May Extend Dating on Product by Adding
2B0307Sterile water for Injection, USP, in Viaflex Plastic Container, Pharmacy Bulk Package (NDC 0338-0013-08)12 months15 months3 months
2B09730.4% Lidocaine HCl & 5% Dextrose Injection, USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch18 months18 months + 13 days13 days
2B13000.9% NaCl Injection USP in 25 mL Viaflex Container with 10 mil HDPE Overpouch – Quad Pack9 months18 months9 months
2B0823Potassium Chloride Injection 30 mEq
in 100 mL Viaflex Container with 10 mil HDPE Overpouch
12 months18 months6 months
2B0824Potassium Chloride Injection 40 mEq
in 100 mL Viaflex Container with 10 mil HDPE Overpouch
12 months18 months6 months
2B0826Potassium Chloride Injection
10 mEq/100 mL Viaflex Container with
10 mil HDPE Overpouch
12 months18 months6 months
2B0827Potassium Chloride Injection
20 mEq/100 mL Viaflex Container with
10 mil HDPE Overpouch
12 months18 months6 months
2B00405% Dextrose Injection USP in 50 mL
Mini-Bag Plus Viaflex Container with 10 mil HDPE Overpouch – Quad Pack
12 months18 months6 months
2B00415% Dextrose Injection USP in 100 mL
Mini-Bag Plus Viaflex Container with 10 mil HDPE Overpouch – Quad Pack
12 months18 months6 months
2B00420.9% NaCl Injection USP in 50 mL
Mini-Bag Plus Viaflex Container with
10 mil HDPE Overpouch – Quad Pack
12 months18 months6 months
2B00430.9% NaCl Injection USP in 100 mL
Mini-Bag Plus Viaflex Container with
10 mil HDPE Overpouch – Quad Pack
12 months18 months6 months
2D5613Q10% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months18 months3 months
2D5623Q15% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months20 months5 months
2D5633Q20% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months18 months3 months
2B2322QLactated Ringers Injection USP in 250 mL Viaflex Container with 6.5 mil HDPE Overpouch18 months18 months + 21 days21 days
2B2323QLactated Ringers Injection USP in500 mL Viaflex Container with 4.5 mil HDPE Overpouch15 months19 months4 months
2B1323Q0.9% NaCl Injection USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch15 months19 months4 months

HDPE – High Density Polyethylene

Page Last Updated: 05/21/2018
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