Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Lisinopril Tablets USP, 40 mg in 1000-count bottles due to manufacturing quality deviations. The active pharmaceutical ingredients used to make the finished product contained intermediates that failed required specifications. The recall affects 5,880 bottles with batch number H303449 and expiration date 09/16, all of which were distributed domestically in the United States.
The source document does not specify what consumers or patients should do regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Reason for recall: CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. Distribution: All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin. Quantity: 5,880 bottles Lot/code info: Batch number: H303449, Exp 09/16
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.