PrednisoLONE Sodium Phosphate Orally Disintegrating recall: CGMP Deviations
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Why was PrednisoLONE Sodium Phosphate Orally Disintegrating recalled?
CGMP Deviations
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 3082921; Exp. 12/18 3088975; Exp. 06/19
- Product
- PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 3,844 48-count bottles
- Distribution
- Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)