Lisinopril & Hydrochlorothiazide Tables recall: CGMP Deviations
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
Why was Lisinopril & Hydrochlorothiazide Tables recalled?
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: a) H303459, b) H303460, Exp 09/2016
- 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
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 59,520 Bottles
- Distribution
- Nationwide and Puerto Rico
- Recall date
- July 6, 2016
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)