Home / Recalls / Sesderma, SL / D-0848-2016

D-0848-2016 Class II Ongoing

Recalled by Sesderma, SL — Rafelbunol, N/A

FDA drug recall D-0848-2016 was initiated by Sesderma, SL on October 15, 2015 and is designated Class II. Reason for recall: cGMP Deviations; product does not comply with cGMP requirements The recall status is ongoing. Affected quantity: 66 bottles.

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: 66 bottles

Product Description

Repaskin 50 (octocrylene 7%, titanium oxide 2%) Facial Sunscreen gel cream, Broad Spectrum SPF 50, 1.7 fl oz (50 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0011-1

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 51594901, exp 06/18,

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-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-0849-2016 Class II — Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenz (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-0843-2016 Class II — Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. o (October 15, 2015)
D-0842-2016 Class II — Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottl (October 15, 2015)