The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0830-2018·Announced 2018-05-30

Mylan Recalls Prednisolone Sodium Phosphate Orally Disintegrating Tablets

Mylan Pharmaceuticals Inc. is voluntarily recalling PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets due to CGMP deviations.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this recall as Class II. The source text cites CGMP deviations as the reason for recall, which typically falls under moderate severity involving minor labeling errors or low-risk contamination rather than immediate health hazards.

Plain-English summary

Mylan Pharmaceuticals Inc. has initiated a voluntary recall of PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 15 mg. The product is available in 48-count bottles with the National Drug Code (NDC) 00378-4715-22.

The recall covers 9,906 bottles distributed to wholesalers throughout the United States, including Puerto Rico. Affected lots include 3082509 (expiration date 08/18) and 3085901 (expiration date 12/18).

The firm is recalling these products due to Current Good Manufacturing Practice (CGMP) deviations. The U.S. Food and Drug Administration classified this recall as Class II.

Consumers who have this product should check their lot numbers and expiration dates against the information provided above.

The recalled product

Product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Orally Disintegrating Tablets
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 (3)

  • Lot #: 3082509
  • Exp. 08/18 3085901
  • Exp. 12/18

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 3 recalled by Mylan Pharmaceuticals Inc. 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 3 products in this recall →

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