FDA-Drug2023-03-08Class II
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Accord Healthcare, Inc.
Hazard
CGMP Deviations: recalling drug products following an FDA inspection.
Sold states
United States including Puerto Rico and Canada
Affected count
312,864 bottles
Manufactured in
1009 Slater Rd Ste 210B, N/A, Durham, NC, United States
Products
Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-count bottle NDC 16729-281-01, UPC 3 16729 28101 0; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0368-2023Don't want to check this manually?
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