Class II · Moderate risk Ongoing
Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC…
Reason Failed Dissolution Specifications
Is Alprazolam recalled?
33 FDA recalls mention Alprazolam. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Alprazolam.
Class II · Moderate risk Terminated
Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx…
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Terminated
Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c)…
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Terminated
Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge…
Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
Class II · Moderate risk Ongoing
Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing
Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only…
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Ongoing
Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534, NDC…
Reason CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05)…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c)…
Reason CGMP Deviations: Potential risk of Cross Contamination
Class II · Moderate risk Terminated
Xanax XR (alprazolam) extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by Pharmacia & Upjohn Co, Division of…
Reason Failed Dissolution Specifications: low out of specification results for dissolution.
Class II · Moderate risk Terminated
alprazolam XR extended-release tablets, 3 mg, 60-count bottle, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC…
Reason Failed Dissolution Specifications: low out-of-specification dissolution test results observed.
Class II · Moderate risk Terminated
Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed…
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk Terminated
Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed…
Reason CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc…
Reason CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle…
Reason CGMP deviations
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and…
Reason cGMP Deviations
Class II · Moderate risk Terminated
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…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50)…
Reason cGMP Deviations
Class II · Moderate risk Terminated
Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505…
Reason Presence of Foreign Substance
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…
Reason Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Class II · Moderate risk Terminated
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private…
Reason Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class III · Low risk Terminated
Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton…
Reason Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot…
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