"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Drug induced methemoglobinemia.
DOSAGE AND ADMINISTRATION
0.1 to 0.2 mL per kilogram of body weight (0.045 to 0.09 mL per pound of body weight). Inject Methylene Blue (methylene blue injection) intravenously very slowly over a period of several minutes.
Methylene Blue (methylene blue injection) Injection, USP, 1% is supplied as follows:
1 mL in 2 cc (partially filled) vials in packages of 10.
10 mL vials in packages of 10.
NDC 11098-520-01 1 mL ampules in packages of 10.
NDC 11098-520-10 10 mL ampules in packages of 10.
The vials are packaged with a Flip Tear-Off Seal. The seal can either be flipped normally to reveal the rubber stopper or be totally removed so the rubber stopper can be taken out of the vial. The plastic button is attached to the metal seal, which when pulled, tears the seal at the score line allowing the metal portion to be removed.
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].
Flip Tear-Off Seal: Directions for Use:
- With the thumb, flip the plastic button up to reveal the rubber stopper.
- Pull the button to tear the seal at the score line and twist to remove.
Taylor Pharmaceuticals, An Akorn Company, Decatur, Illinois 62522. Rev. 03/06. FDA rev date: n/a
Last reviewed on RxList: 7/22/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Methylene Blue Information
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