FDA-Drug2024-12-25Class II
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Macleods Pharmaceuticals Ltd
Hazard
Failed Impurities/Degradation Specifications
Sold states
Nationwide in the USA
Affected count
15,744 30-count bottles
Manufactured in
304 Atlanta Arcade, Church Road, Mumbai, India
Products
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Princeton, NJ,08540: Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-067-07.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0154-2025Don't want to check this manually?
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