Screenses Color Sunscreen
cGMP Deviations; product does not comply with cGMP requirements
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
cGMP Deviations; trailer may not have met GMP requirements prior to filling
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.
Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, Independence, OH --- NDC 33237-001-01
Compare with the code on your package — it is the most precise check available.
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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
cGMP Deviations; product does not comply with cGMP requirements
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