PredniSONE Tablets Recalled for Temperature Storage Deviation
Cardinal Healthcare is recalling PredniSONE 20 mg tablets nationwide (Batch 21P0659, NDC 59746-175-06) due to exposure to temperatures outside labeled storage conditions during manufacture, which could affect drug stability.
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: FDA Class II manufacturing deviation with no reported illnesses or injuries. Temperature exposure outside storage conditions presents a theoretical risk to drug stability and potency, but no actual harm has been documented.
Plain-English summary
Cardinal Healthcare is recalling PredniSONE Tablets, USP, 20 mg (Batch 21P0659, NDC 59746-175-06) manufactured by Jubilant Cadista Pharmaceuticals Inc. The products were exposed to temperatures outside the labeled storage conditions during manufacturing, which violates Current Good Manufacturing Practice (CGMP) standards.
Temperature exposure outside specified storage ranges can affect the stability and potency of pharmaceutical products. While no illnesses or adverse events have been reported, the recall is being issued to prevent potential loss of medication efficacy for patients who depend on this drug.
The recall affects all units distributed nationwide under batch number 21P0659. Patients taking PredniSONE from this batch should contact their healthcare provider or pharmacist about obtaining a replacement supply from an unaffected batch. Healthcare providers and pharmacies should discontinue dispensing and quarantine all remaining inventory of the affected batch.
The recalled product
- Product
- PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
- Manufacturer
- CARDINAL HEALTHCARE
- Category
- Drug — Corticosteroid
- Affected units
- 1
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 21P0659
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 42 recalled by CARDINAL HEALTHCARE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 42 products in this recall →Related recalls
Same manufacturer · CARDINAL HEALTHCARE
See all →- HighAlbuterol Sulfate Inhaler Recalled Due to Temperature Storage Deviation
FDA (Drugs) · 2024-01-03
- ModerateMeloxicam 15 mg tablets recalled for exposure to improper storage temperatures
FDA (Drugs) · 2024-01-03
- HighLow-dose aspirin recall due to improper storage temperature conditions
FDA (Drugs) · 2024-01-03
- HighBumetanide Tablets Recalled for Exposure to Improper Storage Temperatures
FDA (Drugs) · 2024-01-03
- HighLithium Carbonate Extended-Release Tablets Recalled for Temperature Excursion
FDA (Drugs) · 2024-01-03
Same hazard · temperature exposure
See all →- ModerateQuantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
FDA (Devices) · 2024-10-30
- ModerateAllopurinol tablets recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- HighAmoxicillin tablets recalled due to improper storage temperature exposure
FDA (Drugs) · 2024-01-03
- HighRespiratory inhalation medication recalled for temperature storage deviation
FDA (Drugs) · 2024-01-03
- HighRivastigmine Transdermal Patch Recalled Due to Temperature Exposure
FDA (Drugs) · 2024-01-03
Similar recalls
- LowJubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure
FDA (Drugs) · 2018-09-26
- ModerateCardinal Health Recalls Valsartan Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- ModerateCardinal Health Recalls Phenobarbital Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- LowJubilant Cadista Recalls Methylprednisolone Tablets Due to Incorrect Expiration Date Labeling
FDA (Drugs) · 2016-12-21
- LowJubilant Cadista Recalls Methylprednisolone Tablets Due to Illegible Labeling
FDA (Drugs) · 2021-03-10
- ModerateCardinal Health Recalls Pantoprazole Sodium Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02