Jubilant Cadista Recalls Methylprednisolone Tablets for Stability Failure
Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets due to failed stability testing. The product was distributed throughout the United States.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a stability specification failure without reported injuries or illnesses.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, 21-count blister pack (NDC 59746-001-03). The recall involves 89,722 blister packs from Lot # 17P0078 with an expiration date of 12/2018.
The recall was initiated because an out-of-specification result was obtained during 18-month stability testing for assay. This indicates the product may not meet the required stability specifications.
The product was distributed throughout the United States. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for further instructions.
The recalled product
- Product
- MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 89,722
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 (2)
- Lot # 17P0078
- exp. date 12/2018
Distribution
Distribution scope not specified by the agency.
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