FDA-Drug2023-09-27Class II

Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Aurobindo Pharma USA Inc.
Hazard

Failed dissolution specifications - results obtained were below spec average.

Sold states
USA nationwide
Affected count
9,890 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1171-2023

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