Recalls / Class III
Class IIID-1052-2016
Product
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
- Brand name
- Lisinopril And Hydrochlorothiazide
- Generic name
- Lisinopril And Hydrochlorothiazide
- Active ingredients
- Hydrochlorothiazide, Lisinopril
- Route
- Oral
- NDCs
- 68180-518, 68180-519, 68180-520
- FDA application
- ANDA077912
- Affected lot / code info
- Lot #: a) H303459, b) H303460, Exp 09/2016
Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 59,520 Bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2016-04-04
- FDA classified
- 2016-06-24
- Posted by FDA
- 2016-07-06
- Terminated
- 2017-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1052-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.