Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Salises Facial Moisturizing Acne Treatment Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations; product does not comply with cGMP requirements
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDC
63181-0016
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Sesderma, SL
- Origin
- N/A, Spain
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0843-2016 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Sesderma, SL
All 2015 recalls
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 50
cGMP Deviations; product does not comply with cGMP requirements
Other cgmp deviation recalls from 2015
All cgmp deviation recalls
Class II · Moderate risk
Oxygen
cGMP Deviations; trailer may not have met GMP requirements prior to filling
Class II · Moderate risk
Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Screenses Color Sunscreen Tinted facial make-up compact
cGMP Deviations; product does not comply with cGMP requirements
Class II · Moderate risk
Repaskin 30
cGMP Deviations; product does not comply with cGMP requirements
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