Exact FDA event identifier

Event 80006

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

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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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
Recalling firm: Mylan Pharmaceuticals Inc.
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
Recalling firm: Mylan Pharmaceuticals Inc.
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
Recalling firm: Mylan Pharmaceuticals Inc.
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.