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

Code

Product Description

Current Shelf Life (month/year)

Extended
Shelf Life
(month/year)

End-User May Extend
Dating on Product by Adding

2B0973

0.4% Lidocaine HCl & 5% Dextrose Injection, USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch

18 months18 months + 13 days13 days
2B1300

0.9% NaCl Injection USP in 25 mL Viaflex Container with 10 mil HDPE Overpouch – Quad Pack

9 months18 months9 months
2B0823

Potassium Chloride Injection 30 mEq
in 100 mL Viaflex Container with 10 mil HDPE Overpouch

12 months18 months6 months
2B0824

Potassium Chloride Injection 40 mEq
in 100 mL Viaflex Container with 10 mil HDPE Overpouch

12 months18 months6 months
2B0826

Potassium Chloride Injection
10 mEq/100 mL Viaflex Container with
10 mil HDPE Overpouch

12 months18 months6 months
2B0827

Potassium Chloride Injection
20 mEq/100 mL Viaflex Container with
10 mil HDPE Overpouch

12 months18 months6 months
2B0040

5% Dextrose Injection USP in 50 mL
Mini-Bag Plus Viaflex Container with 10 mil HDPE Overpouch – Quad Pack

12 months18 months6 months
2B0041

5% Dextrose Injection USP in 100 mL
Mini-Bag Plus Viaflex Container with 10 mil HDPE Overpouch – Quad Pack

12 months18 months6 months
2B0042

0.9% NaCl Injection USP in 50 mL
Mini-Bag Plus Viaflex Container with
10 mil HDPE Overpouch – Quad Pack

12 months18 months6 months
2B0043

0.9% NaCl Injection USP in 100 mL
Mini-Bag Plus Viaflex Container with
10 mil HDPE Overpouch – Quad Pack

12 months18 months6 months
2D5613Q

10% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch

15 months18 months3 months
2D5623Q

15% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch

15 months20 months5 months
2D5633Q

20% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch

15 months18 months3 months

HDPE – High Density Polyethylene

Page Last Updated: 01/31/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English