Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0831-2018·Announced 2018-05-30

Mylan Recalls Prednisolone Sodium Phosphate Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is voluntarily recalling specific lots of Prednisolone Sodium Phosphate tablets due to Current Good Manufacturing Practice (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 recall is classified as FDA Class II, which typically involves a situation that could cause temporary or medically reversible health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, aligning with the 'Moderate' criteria for voluntary precautionary recalls or minor labeling/quality errors.

Plain-English summary

Mylan Pharmaceuticals Inc. is voluntarily recalling 3,844 bottles of PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle (NDC 00378-4730-22). The recall was initiated on April 30, 2018, and was classified as Class II by the FDA. The reason for the recall is identified as Current Good Manufacturing Practice (CGMP) deviations.

The affected product includes Lot # 3082921 with an expiration date of 12/18 and Lot # 3088975 with an expiration date of 06/19. Mylan Pharmaceuticals distributed these products to wholesalers throughout the United States, including Puerto Rico. The recall status is currently terminated, with a termination date of February 14, 2019.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the wholesaler or pharmacy for disposal or credit in accordance with the recalling firm's instructions. No specific illnesses or injuries have been reported in the source text.

The recalled product

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
Manufacturer: Mylan Pharmaceuticals Inc.
Category: Drug — Prescription Medication
Hazard: cgmp-deviation

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 #: 3082921
Exp. 12/18 3088975
Exp. 06/19

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 →

Same manufacturer · Mylan Pharmaceuticals Inc.

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Same hazard · cgmp deviation