The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0829-2018·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 Orally Disintegrating 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 may cause temporary or medically reversible health consequences. The source cites CGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall.

Plain-English summary

Mylan Pharmaceuticals Inc. is voluntarily recalling 7,334 bottles of Prednisolone Sodium Phosphate Orally Disintegrating Tablets, 10 mg, 48-count. The recall was initiated on April 30, 2018, and was classified as Class II by the FDA. The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations.

The affected product is distributed to wholesalers throughout the United States, including Puerto Rico. The specific lots subject to recall are 3081542, 3081543, 3081544, and 3082235 (all with an expiration date of 08/18), 3085903 (expiration 12/18), 3088974 (expiration 06/19), and 3090445 (expiration 06/19). The National Drug Code (NDC) for the product is 00378-4710-22.

Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. The recall status is currently terminated as of February 14, 2019. Mylan notified the initial firm via letter.

The recalled product

Product
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
Manufacturer
Mylan Pharmaceuticals Inc.
Category
Drug — Prescription Medication
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 (8)

  • Lot #: 3081542
  • Exp. 08/18 3081543
  • Exp. 08/18 3081544
  • Exp. 08/18 3082235
  • Exp. 08/18 3085903
  • Exp. 12/18 3088974
  • Exp. 06/19 3090445
  • 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 →

Related recalls

Same manufacturer · Mylan Pharmaceuticals Inc.

See all →

Same hazard · cgmp deviations

See all →

Similar recalls