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
Product description
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
Lot numbers, UPCs & expiration codes
Batch Number PE190701e1 with expiry June 2021
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1508-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 10, 2020
- FDA report date
- Aug 26, 2020
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lannett Company, Inc.
Original FDA data
Every field from FDA enforcement report D-1508-2020, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 86130
- Address
- 9000 State Rd
- Code information
- Batch Number PE190701e1 with expiry June 2021
- Postal code
- 19136-1615
- Report date
- Aug 26, 2020
- Product type
- Drugs
- Recall number
- D-1508-2020
- Classification
- Class II
- Recalling firm
- Lannett Company, Inc.
- Termination date
- Jul 22, 2022
- Reason for recall
- Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- Aug 10, 2020
- Initial firm notification
- Letter
- Center classification date
- Aug 17, 2020