Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.
Check against the official notice below — it lists the full affected range.
Lupin Pharmaceuticals Inc. is recalling Lisinopril Tablets USP, 30 mg, in both 500-count bottles (NDC 68180-516-02) and 100-count bottles (NDC 68180-516-01) due to Current Good Manufacturing Practice (CGMP) deviations. The affected finished products were manufactured using active pharmaceutical ingredients whose intermediates failed to meet specifications. A total of 20,556 bottles were distributed, all within the United States, with batch numbers H303487, H303488, and H303489, expiring in September 2016.
The recalled product was distributed domestically in the US only, and was not distributed to U.S. Government Agency consignees or any foreign consignees directly by Lupin. The source document does not specify what remedy consumers should pursue.
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: 20,556 bottles Lot/code info: Batch number: H303487, H303488, H303489, Exp 09/16
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.