Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Acetylcysteine 2% Otic Drop
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Processing Controls
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
Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.
Drug: Acetylcysteine
- Recalling firm
- Wise Pharmacy
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1567-2019 · 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 Acetylcysteine recalls
See all
Class II · Moderate risk
Acetylcysteine Solution
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Class II · Moderate risk
Acetylcysteine 10% Ophthalmic Solution
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 5% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Class II · Moderate risk
ACETYLCYSTEINE OPTH 10% Solution
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Other recalls by Wise Pharmacy
All 2019 recalls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil/Atropine 30 mg/2 mg/50 mcg/0.15 mg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/50 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil 30 mg/2 mg/30 mcg/mL Injectable
Lack of Processing Controls
Class II · Moderate risk
Papaverine/Phentolamine/Alprostadil - 30 mg/1 mg/10 mcg/mL Injectable
Lack of Processing Controls
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