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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80006

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 30, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 3

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22

D-0829-2018
Recall number
D-0829-2018
Initiated
April 30, 2018
Classification
Class II
Status
Terminated
Quantity
7,334 48-count bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code 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

Distribution pattern

Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

drug · product 2 of 3

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

D-0830-2018
Recall number
D-0830-2018
Initiated
April 30, 2018
Classification
Class II
Status
Terminated
Quantity
9,906 48-count bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

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

Distribution pattern

Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

drug · product 3 of 3

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22

D-0831-2018
Recall number
D-0831-2018
Initiated
April 30, 2018
Classification
Class II
Status
Terminated
Quantity
3,844 48-count bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations

Code information

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

Distribution pattern

Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.