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Medicine / D-0867-2026

U.S. Food and Drug AdministrationD-0867-2026

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods…

Class III Distributed nationwide or U.S.-wide Status: Ongoing

What was recalled

Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.

Recalling firm

Macleods Pharmaceuticals Limited

Reason for recall

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

Where it went

Nationwide in the USA

Shown as U.S. Food and Drug Administration published it (shortened where marked …). Recall Shelf does not change recall facts and is not affiliated with the agency.