Recalls / Class II
Class IID-0829-2018
Product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
- Affected lot / code info
- Lot #: 3081542, Exp. 08/18 3081543, Exp. 08/18 3081544, Exp. 08/18 3082235, Exp. 08/18 3085903, Exp. 12/18 3088974, Exp. 06/19 3090445, Exp. 06/19
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
- 7,334 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-0829-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.