Exact FDA event identifier

Event 79860

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

Event summary

Timeline bucket: April 13, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Lyne Laboratories, 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

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043

D-0711-2018

Recall number: D-0711-2018
Initiated: April 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Lyne Laboratories, Inc.
Quantity: 12572 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot #: FR1603, FR1604A, Exp. 05/2018

Distribution pattern

to be entered

drug · product 2 of 3

Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200

D-0712-2018

Recall number: D-0712-2018
Initiated: April 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Lyne Laboratories, Inc.
Quantity: 17939 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot#: FR1604B, FR1604C, FR 1604D, Exp. 06/2018

Distribution pattern

to be entered

drug · product 3 of 3

Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046

D-0713-2018

Recall number: D-0713-2018
Initiated: April 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Lyne Laboratories, Inc.
Quantity: 23453 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot #: FR1601, FR1602, Exp. 05/2018

Distribution pattern

to be entered