Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Alprazolam Tab
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge Pharmaceuticals, Inc., Boca Raton, FL. Ins:NDC 68788-7594-3
Affected NDC
68788-7594-03
Compare with the code on your package — it is the most precise check available.
Drug: Alprazolam Category: Mental Health Medication
- Recalling firm
- Preferred Pharmaceuticals, Inc.
- NDC code
- 68788-7594-3
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0504-2023 · 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 C-IV
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
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 Preferred Pharmaceuticals, Inc.
All 2023 recalls
Class II · Moderate risk
Artificial Tears Lubricant Eye Drops
Lack of Assurance of Sterility
Class II · Moderate risk
Ondansetron ODT Tablets
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk
Clindamycin Hydrochloride Capsules
cGMP Deviations
Class II · Moderate risk
Ibuprofen Tablets
Failed Impurities/Degradation Specifications - at 18-month Stability testing
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