PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: May 2, 2018 Initiated: April 13, 2018 #D-0711-2018

Product Description

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

Reason for Recall

Subpotent Drug

Details

Recalling Firm
Lyne Laboratories, Inc.
Units Affected
12572 units
Distribution
to be entered
Location
Brockton, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Lyne Laboratories, Inc.. Units affected: 12572 units.
Why was this product recalled?
Subpotent Drug
Which agency issued this recall?
This recall was issued by the FDA Drug on May 2, 2018. Severity: Moderate. Recall number: D-0711-2018.