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
2D5613Q 10% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months 18 months 3 months
2D5623Q 15% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months 20 months 5 months
2D5633Q 20% Osmitrol (Mannitol) in Water in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months 18 months 3 months
2B2322Q Lactated Ringers Injection USP in
250 mL Viaflex Container with 6.5 mil HDPE Overpouch
18 months 18 months +
21 days
21 days
2B2323Q Lactated Ringers Injection USP in
500 mL Viaflex Container with 4.5 mil HDPE Overpouch
15 months 19 months 4 months
2B1323N 0.9% NaCl Injection USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch 15 months 19 months 4 months
2B1323NF 0.9% NaCl Injection USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch 15 months 19 months 4 months
2B1323Q 0.9% NaCl Injection USP in 500 mL Viaflex Container with 4.5 mil HDPE Overpouch 15 months 19 months 4 months

HDPE – High Density Polyethylene

 

Original article can be accessed here.

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