Home / Recalls / The Mentholatum Co. / D-1038-2014

D-1038-2014 Class II Terminated

Recalled by The Mentholatum Co. — Orchard Park, NY

FDA drug recall D-1038-2014 was initiated by The Mentholatum Co. on January 16, 2014 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of st… The recall status is terminated (terminated June 1, 2018). Affected quantity: 94,080 units Total (432 units held in stock, quarantined).

Recall Details

Product Type
Drugs
Report Date
February 5, 2014
Initiation Date
January 16, 2014
Termination Date
June 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94,080 units Total (432 units held in stock, quarantined)

Product Description

ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.

Reason for Recall

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Stock No: 1086; Case UPC: 3 10742 91086 (5); Item UPC 3 10742 01086 2

Other recalls by The Mentholatum Co.

  • D-1541-2020 Class III — Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 Fl. (July 31, 2020)
  • D-0018-2016 Class II — WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analg (September 17, 2015)
  • D-1039-2014 Class II — ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). (January 16, 2014)
  • D-1037-2014 Class II — ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Ne (January 16, 2014)
  • D-1040-2014 Class II — ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, L (January 16, 2014)
  • D-1041-2014 Class II — ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. (January 16, 2014)

FDA data resources