The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0205-2017·Announced 2016-12-21

Jubilant Cadista Recalls Methylprednisolone Tablets Due to Incorrect Expiration Date Labeling

Jubilant Cadista Pharmaceuticals is recalling 1,512 bottles of Methylprednisolone Tablets, USP, 16 mg, because the expiration date is printed incorrectly as 02/0218 instead of 02/2018.

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 FDA classified this as a Class III recall, 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 documentation/labeling error.

Plain-English summary

Jubilant Cadista Pharmaceuticals, Inc. is recalling 1,512 bottles of Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only. The product is manufactured by Jubilant Cadista Pharmaceuticals Inc. in Salisbury, MD, and carries NDC 59746-003-14.

The recall is due to a labeling error where the expiration date is printed as 02/0218 instead of the correct date of 02/2018. The affected lot number is 16P0176. The FDA has classified this as a Class III recall, indicating that the product is unlikely to cause adverse health consequences.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for this specific lot and expiration date error. As this is a prescription-only medication, patients should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
Manufacturer
Jubilant Cadista Pharmaceuticals, Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
1,512

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 #: 16P0176
  • Exp 02/2018 but labeled incorrectly as 02/0218.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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