Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Alprazolam Tablets
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
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
Affected NDCs
67253-0901-10
67253-0901-11
67253-0901-50
Compare with the code on your package — it is the most precise check available.
Drug: Alprazolam Category: Mental Health Medication
- Recalling firm
- ANI Pharmaceuticals, Inc.
- NDC code
- 67253-901-10
- Origin
- MN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0565-2022 · 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 Alprazolam recalls
See all
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Alprazolam Tab
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk
Alprazolam C-IV
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Other recalls by ANI Pharmaceuticals, Inc.
All 2022 recalls
Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Class II · Moderate risk
Estradiol Gel
Defective Container; packets were found to be either empty or partially full.
Class II · Moderate risk
Pyrazinamide Tablets
cGMP Deviations
Class II · Moderate risk
Alprazolam Tablets
cGMP Deviations
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