Alprazolam Extended-release Tablets, USP, 1 mg, 60-count bottle, Rx Only, Manufactured and Distributed by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5022-91
Mylan Pharmaceuticals
Failed Dissolution Specifications
Prescription and over-the-counter medications
Mylan Pharmaceuticals
Failed Dissolution Specifications
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Failed Stability Specifications: Out of Specification results obtained for preservative Methylparaben content.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
cGMP Deviations: lack of quality assurance at the API manufacturer.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Advanced Pharma
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.