Home / Recalls / Lyne Laboratories, Inc. / D-0712-2018

D-0712-2018 Class II Terminated

Recalled by Lyne Laboratories, Inc. — Brockton, MA

Recall Details

Product Type
Drugs
Report Date
May 2, 2018
Initiation Date
April 13, 2018
Termination Date
May 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
17939 units

Product Description

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

Reason for Recall

Subpotent Drug

Distribution Pattern

to be entered

Code Information

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

Other recalls by Lyne Laboratories, Inc.

  • D-0711-2018 Class II — Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx On (April 13, 2018)
  • D-0713-2018 Class II — Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx On (April 13, 2018)
  • D-1062-2016 Class III — Cyproheptadine Hydrochloride Syrup, Oral Solution USP, 2 mg/5 mL, packaged in an (June 7, 2016)