Drug recall: Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by…
Class II FDA enforcement event 73574. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
cGMP Deviations; product does not comply with cGMP requirements
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
The recalling firm started this drug recall on 15 Oct 2015. The FDA record names a person as the firm, and this site does not show the name. The firm address in the FDA record is in Rafelbunol. FDA put the recall in Class II. FDA event 73574 has 10 product records. The first FDA enforcement report date is 18 May 2016. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Distributed to following states: FL, PR, CO, GA.
Recalling firm
The name is withheld, Rafelbunol, N/A, Spain.
The FDA record gives the name of a person as the recalling firm. This site does not show the names of persons.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
10 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0842-2016 | Dryses Aluminum Chlorohydrate Antiperspirant Solution, 3.4 fl. oz (100 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0015-1, UPC 8 470003 244268 | 542 bottles | Class II | Ongoing | 18 May 2016 |
| D-0843-2016 | Salises Facial Moisturizing Acne Treatment Gel, (salicylic acid 1.5%), 1.7 fl. oz (50 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain --- NDC 63181-0016 | 459 bottles | Class II | Ongoing | 18 May 2016 |
| D-0844-2016 | 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 | 15 bottles | Class II | Ongoing | 18 May 2016 |
| D-0845-2016 | Repaskin 30 (octacrylene 4%, oxybenzone 3%, octisalate 3%, octinoxate 3% Avobenzone 3%) Body Lotion Sunscreen gel cream, Broad Spectrum SPF 30, 6.8 fl oz (200 mL) tube, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0012-1 UPC8 429979 415691 | 20 bottles | Class II | Ongoing | 18 May 2016 |
| D-0846-2016 | Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 63181-0019-1 UPC 8 470002 075221 | 354 bottles | Class II | Ongoing | 18 May 2016 |
| D-0847-2016 | Dryses Aluminum Chlorohydrate Deodorant for Women, Roll-on, 2.5 fl oz (75 mL) bottle, over the counter, Manufactured by Sesderma S.L., Valencia, Spain, NDC 16047-0029-1 | 195 bottles | Class II | Ongoing | 18 May 2016 |
| D-0848-2016 | 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 | 66 bottles | Class II | Ongoing | 18 May 2016 |
| D-0849-2016 | 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 | 27 bottles | Class II | Ongoing | 18 May 2016 |
| D-0850-2016 | Screenses Color Sunscreen Tinted facial make-up compact, Broad Spectrum SPF 50, Brown, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252166 | 45 compacts | Class II | Ongoing | 18 May 2016 |
| D-0851-2016 | Screenses Color Sunscreen, Tinted facial make-up compact, Broad Spectrum SPF 50 Light, 0.35 oz (10 g), Manufactured by Sesderma S.L., Valencia, Spain, UPC 8 429979 252159 | 44 compacts | Class II | Ongoing | 18 May 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2015
- 292
- Share of these events in Class II
- 52%
- Product records in this event
- 10
Official channels
- FDA enforcement report D-0842-2016The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 73574. https://recallregister.com/fda/ii/73574/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Distributed to following states: FL, PR, CO, GA.
- What quantity of product is in FDA event 73574?
- The event has 10 product records. The first record gives this quantity:
542 bottles
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2015 have the same class?
- 52% of the 292 drug events that started in 2015 are in Class II.