D-0156-2024 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 27, 2023
- Initiation Date
- December 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 containers
Product Description
NYSTATIN 2 BU, 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 51552-0041-4, Bar code 3 51552 00414 6
Reason for Recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
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.
Code Information
Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025