Recalls / Class II
Class IID-0830-2018
Product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
- Affected lot / code info
- Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 9,906 48-count bottles
- Distribution pattern
- Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Timeline
- Recall initiated
- 2018-04-30
- FDA classified
- 2018-05-22
- Posted by FDA
- 2018-05-30
- Terminated
- 2019-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0830-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.