Class II · Moderate risk
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
All budesonide Products
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
All budesonide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Drug: Budesonide
- Recalling firm
- Reliable Rexall-A Compounding Pharmacy
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1087-2016 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Budesonide recalls
See all
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
Airsupra (albuterol and budesonide)
Defective delivery system
Class II · Moderate risk
Budesonide
CGMP Deviations and Presence of Particulate Matter: Glass
Class II · Moderate risk
Budesonide Extended-Release Tablets
Failed Dissolution Specifications
Other recalls by Reliable Rexall-A Compounding Pharmacy
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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