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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66607

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

Open FDA event record

Event summary

Timeline bucket
September 26, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

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

2 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 2

CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.

D-0377-2015
Recall number
D-0377-2015
Initiated
September 26, 2013
Classification
Class II
Status
Terminated
Quantity
11,650 cartons

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: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Code information

Lot Number: 3034630; Expiration Date: 12/13; NDC: 51079-182-20

Distribution pattern

Nationwide and Puerto Rico.

drug · product 2 of 2

LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20

D-0378-2015
Recall number
D-0378-2015
Initiated
September 26, 2013
Classification
Class II
Status
Terminated
Quantity
3,993 cartons

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: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Code information

Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;

Distribution pattern

Nationwide and Puerto Rico.