Class II · Moderate risk
Auryxia (ferric citrate)
CGMP Deviations
Bersih Hand Sanitizer Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviations
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
Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Distributed by RediBag USA 135 Fulton Ave New Hyde Park, NY 11040 UPC 8 16822 02666 7
- Recalling firm
- Soluciones Cosmeticas, SA de CV
- Origin
- N/A, Mexico
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 14, 2020 · FDA notice with lot numbers
- FDA recall number
- D-1560-2020 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other cgmp deviation recalls from 2020
All cgmp deviation recalls
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Imatinib Mesylate Tablets 100 mg
CGMP Deviations
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