FDA-Drug2020-07-01Class II
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Alembic Pharmaceuticals Limited
Hazard
Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.
Sold states
Nationwide in the U.S.
Affected count
19,153 bottles
Manufactured in
Near Baska, N/A, Tajpura, N/A, India
Products
Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 389350, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA, NDC 62332-097-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1341-2020Don't want to check this manually?
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