FDA label a50b0fec-0672-4992-a736-c4ecd6a079eb

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
4d08424e-1ae1-41a4-b50b-e4ce4b828bdd
SPL ID
a50b0fec-0672-4992-a736-c4ecd6a079eb
Version
4
Effective date
2025-01-17
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:14:25

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

5. WARNINGS AND PRECAUTIONS 5.1. Rx ONLY. 5.2. Do not use unless solutions are clear and free from particulates. 5.3. Always inspect the blood bag set for leaks before use. 5.4. Avoid excessive heat and direct sunlight. Protect from freezing. 5.5. Recommended storage conditions: Room Temperature (15-30°C/59-86°F). 5.6. It is normal to have condensation in the aluminum foil pack. If the amount of moisture is greater than expected, check for leaks from the fluid-filled components of the blood bag set. 5.7. Use aseptic techniques. 5.8. Do not use a dielectric tube sealer to seal the tubing while the needle is connected to the donor's body unless it is approved for such a purpose. 5.9. Do not touch needle after removing the needle cover. 5.10. Do not collect donor test samples until the tubing between the "Y" and the diversion pouch is permanently sealed. 5.11. Discard the Diversion Blood Sampling Arm and phlebotomy needle/donor tubing according to institutional standard operating procedures. 5.12. Each aluminum foil pack contains a sachet that absorbs oxygen and generates heat on contact with air. The sachet should be handled with caution. 5.12.1. Do not open the oxygen absorber sachet. 5.12.2. Dispose of the aluminum foil pack with the oxygen absorber sachet in the pack. 5.12.3. Do not dispose of the aluminum foil pack containing the oxygen absorber sachet together with waste containing volatile or flammable material. 5.13. Due to possible exposure to infectious agents in the handling of blood, take adequate precautions at all times to prevent exposure to and transmission of such agents. Follow your institution's standard operating procedures.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.