Multi-event April 2018 FDA Recall Drug by Mylan Pharmaceuticals Inc.

This Multi-event Class II drug recall was voluntarily initiated by Mylan Pharmaceuticals Inc. on April 30, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico. and the recall is currently terminated.

Reported Recall Events

D-0831-2018 TERMINATED D-0829-2018 TERMINATED D-0830-2018 TERMINATED

Recall Number: D-0831-2018

Reason for Recall
CGMP Deviations
Initiated
04-30-2018
Reported
05-30-2018
Quantity
3,844 48-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80006
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2019
Product Description About Product Description
Full technical description of the product.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22

Batch or Lot Expiration Information

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

Recall Number: D-0829-2018

Reason for Recall
CGMP Deviations
Initiated
04-30-2018
Reported
05-30-2018
Quantity
7,334 48-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80006
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2019
Product Description About Product Description
Full technical description of the product.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

Batch or Lot Expiration Information

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

Recall Number: D-0830-2018

Reason for Recall
CGMP Deviations
Initiated
04-30-2018
Reported
05-30-2018
Quantity
9,906 48-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
80006
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Mylan Pharmaceuticals Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-14-2019
Product Description About Product Description
Full technical description of the product.
PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

Batch or Lot Expiration Information

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