Multi-event April 2018 FDA Recall Fluocinolone Acetonide by Lyne Laboratories, Inc.

This Multi-event Class II drug recall was voluntarily initiated by Lyne Laboratories, Inc. on April 13, 2018 for the product Fluocinolone Acetonide. The FDA reported the reason for recall as subpotent drug. The product was distributed in to be entered and the recall is currently terminated.

Reported Recall Events

D-0712-2018 TERMINATED D-0711-2018 TERMINATED D-0713-2018 TERMINATED

Recall Number: D-0712-2018

Reason for Recall
Subpotent Drug
Initiated
04-13-2018
Reported
05-02-2018
Quantity
17939 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79860
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.
Lyne Laboratories, 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.
to be entered
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

64980-329-20 Fluocinolone Acetonide Oil

Recall Number: D-0711-2018

Reason for Recall
Subpotent Drug
Initiated
04-13-2018
Reported
05-02-2018
Quantity
12572 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79860
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.
Lyne Laboratories, 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.
to be entered
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

64980-331-04 Fluocinolone Acetonide Oil

Recall Number: D-0713-2018

Reason for Recall
Subpotent Drug
Initiated
04-13-2018
Reported
05-02-2018
Quantity
23453 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79860
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.
Lyne Laboratories, 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.
to be entered
Termination Date About Termination Date
Date that FDA officially terminated the recall.
05-16-2019
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

64980-330-04 Fluocinolone Acetonide Oil