Jubilant Cadista Recalls Methylprednisolone Tablets Due to Illegible Labeling
Jubilant Cadista Pharmaceuticals is recalling specific lots of Methylprednisolone Tablets USP, 4 MG, due to misaligned printing on the blister card that makes dosing instructions illegible.
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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a cosmetic/packaging defect (illegible label) rather than a safety hazard.
Plain-English summary
Jubilant Cadista Pharmaceuticals, Inc. is recalling Methylprednisolone Tablets USP, 4 MG, packaged in 21-count blister packs. The recall affects 635,400 cartons distributed nationwide in the United States, including Puerto Rico. The specific lots involved are 20K0043P, 20K0044P, and 20K0042P (expiration 08/2022), and 20L0026P, 20L0027P, 20L0028P, 20L0029P, and 20L0030P (expiration 09/2022).
The recall was initiated after a customer complaint reported misaligned printing of the dosing instructions on the blister card, rendering the label illegible. This is a Class III recall, indicating that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be returned to the supplier or the manufacturer for disposal or credit.
The recalled product
- Product
- Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
- Manufacturer
- Jubilant Cadista Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 635,400
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 (10)
- Lot #: 20K0043P
- 20K0044P
- 20K0042P
- Exp 08/2022
- 20L0026P
- 20L0027P
- 20L0028P
- 20L0029P
- 20L0030P
- Exp 09/2022
Distribution
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