Recalls / Class II
Class IID-1508-2020
Product
Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37
- Affected lot / code info
- Batch Number PE190701e1 with expiry June 2021
Why it was recalled
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
Recalling firm
- Firm
- Lannett Company, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9000 State Rd, N/A, Philadelphia, Pennsylvania 19136-1615
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide
Timeline
- Recall initiated
- 2020-08-10
- FDA classified
- 2020-08-17
- Posted by FDA
- 2020-08-26
- Terminated
- 2022-07-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1508-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.