FDA Recall D-0844-2016

Sesderma, SL · Rafelbunol, N/A

Class II Ongoing 3864 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Repaskin 50 (octocrylene 7%, titanium dioxide 2%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 50, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0013-1, UPC 8 429979 415707

Lot / code: Lot code 41464901, exp 05/17

Quantity: 15 bottles

Reason for recall

cGMP Deviations; product does not comply with cGMP requirements

Recall record

Recall number: D-0844-2016
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Distributed to following states: FL, PR, CO, GA.
Recall initiated: 2015-10-15
Classified by FDA Center: 2016-05-10
FDA published: 2016-05-18
Recalling firm: Sesderma, SL
Firm location: Rafelbunol, N/A, Spain

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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