Class II · Moderate risk
Xanax XR
Failed Dissolution Specifications
Xanax (alprazolam)
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
Xanax (alprazolam) tablets, 0.25 mg, 100-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co. Division of Pfizer Inc, NY, NY 10017, NDC 0009-0029-01
Affected NDC
0009-0029-01
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 |
|---|---|---|---|---|
| Xanax alprazolam NDC 00009-0029 |
.25 mg/1 | Tablet Oral |
Pharmacia & Upjohn Company LLC | Rx · CIV |
- Recalling firm
- Pfizer Inc.
- NDC code
- 0009-0029-01
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0161-2016 · 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 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 Pfizer Inc.
All 2015 recalls
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
Vial Label: 8.4% Sodium Bicarbonate Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Vial Label: Epinephrine Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Subpotent drug
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