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
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Alprazolam tablets, USP, CIV, 0.25 mg, Rx Only, a) 500 count bottle, b) 1000 count bottle, Distributed by: Greenstone LLC, Peapack, NJ, 07977, a) NDC 59762-3719-3, b) NDC 59762-3719-4.
Affected NDCs
59762-3719-03
59762-3719-04
Compare with the code on your package — it is the most precise check available.
Drug: Alprazolam Category: Mental Health Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Alprazolam NDC 59762-3719 |
.25 mg/1 | Tablet Oral |
Mylan Pharmaceuticals Inc. | Rx · CIV |
- Recalling firm
- Neolpharma, Inc.
- NDC code
- 59762-3719-3
- Origin
- PR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0326-2015 · 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 wrong potency / content recalls from 2014
All wrong potency / content recalls
Class II · Moderate risk
Heparin Sodium in 0.9% Sodium Chloride Injection
Subpotent Drug: Heparin raw material was found to have low potency
Class III · Low risk
MethylPREDNISolone Tablets
Subpotent; 6 month stability time point
Class II · Moderate risk
VERSAPHARM INCORPORATED Ethambutol Hydrochloride Tablets
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Class III · Low risk
Locoid (hydrocortisone butyrate 0.1%)
Subpotent Drug; for the active, HCB, and preservatives, Propylparaben and Butylparaben at the 18 month stability test point
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