FDA notification regarding ascorbic acid injection
FDA requested companies stop distributing unapproved versions of ascorbic acid injection.
The agency approved McGuff Pharmaceuticals Inc.’s Ascor (ascorbic acid injection), 500 mg/mL, 50 mL vial (NDC 67175-0101) on October 2, 2017. All other ascorbic acid injection products are unapproved new drugs that should not be distributed in interstate commerce without a new drug application approved by FDA, including:
|
Drug NDC |
Drug name |
|---|---|
|
67457-0118-50 |
Ascorbic Acid for Injection, USP 500 mg/mL, 50 mL |
|
71414-0115-01 |
Ascorbic Acid for Injection, USP 500 mg/mL, 50 mL |
|
00389-0486-10 |
Ascorbic Acid for Injection, USP 500 mg/mL, 50 mL |
FDA encourages all drug companies of unapproved drugs to seek FDA approval. The NDC Directory identifies FDA approval status of all prescription drugs marketed in the United States.