Lannett Recalls Prednisone Tablets Due to Labeling Error
Lannett Company, Inc. is recalling specific batches of Prednisone Tablets due to a labeling error where 2.5 mg bottles contained 10 mg tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a significant dosage discrepancy (2.5 mg vs 10 mg) which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Lannett Company, Inc. is recalling Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only. The recall is due to a labeling error where bottles labeled to contain 2.5 mg tablets actually contained 10 mg tablets.
The affected product is identified by Batch Number PE190701e1 with an expiry date of June 2021. The product was distributed nationwide in the United States. The tablets were manufactured by Tianjin Tianyao Pharmaceuticals Co., Ltd in Tianjin, China, and distributed by Lannett Company, Inc. in Philadelphia, PA.
Consumers and healthcare providers should check their inventory for the specific batch number and expiry date listed above. If the product matches the recalled description, it should be returned to the pharmacy or distributor. Patients should consult their healthcare provider regarding any medication they have already taken from the affected batch.
The recalled product
- 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…
- Manufacturer
- Lannett Company, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch Number PE190701e1 with expiry June 2021
Distribution
Distributed nationwide across the United States.
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