Home / Recalls / Sesderma, SL / D-0849-2016

D-0849-2016 Class II Ongoing

Recalled by Sesderma, SL — Rafelbunol, N/A

Recall Details

Product Type
Drugs
Report Date
May 18, 2016
Initiation Date
October 15, 2015
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27 bottles

Product Description

Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Facial Sunscreen gel cream, Broad Spectrum SPF 30, 1.7 fl oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0010-1

Reason for Recall

cGMP Deviations; product does not comply with cGMP requirements

Distribution Pattern

Distributed to following states: FL, PR, CO, GA.

Code Information

Lot code 51064901, exp 07/17; Lot code 51064902, exp 04/18

Other recalls by Sesderma, SL

  • D-0844-2016 Class II — Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel crea (October 15, 2015)
  • D-0845-2016 Class II — Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenz (October 15, 2015)
  • D-0843-2016 Class II — Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. o (October 15, 2015)
  • D-0847-2016 Class II — Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bo (October 15, 2015)
  • D-0846-2016 Class II — Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottl (October 15, 2015)
  • D-0842-2016 Class II — Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottl (October 15, 2015)
  • D-0851-2016 Class II — Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 (October 15, 2015)
  • D-0850-2016 Class II — Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, (October 15, 2015)
  • D-0848-2016 Class II — Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broa (October 15, 2015)