Recalling firm
Aurobindo Pharma USA Inc.
Product type
Drug
Status
Terminated
Report date
2023-09-27
Distribution
USA nationwide
Firm state
NJ
Product quantity
9,890 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Failed dissolution specifications - results obtained were below spec average.
Product description
Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
Code / lot info
Lot #: 3112444, Exp 8/2023
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.