Status
Ongoing
Drug Enforcement D-0154-2024
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Classification
Class II
Report Date
December 27, 2023
Termination Date
—
Product Information
- Product description
- NYSTATIN 5BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-5 Bar code 3 51552 00415 3
- Product quantity
- 13 containers
- Reason for recall
- Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
Location & Firm
- Recalling firm
- Fagron, Inc
- Address
-
2400 Pilot Knob Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0154-2024
- Event ID
- 93594
- Recall initiation date
- December 11, 2023
- Center classification date
- December 21, 2023
- Code info
- Lot#: 230308-U46196, Exp. date 04/30/2025
- More code info
- —