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
Reported: July 6, 2016 Initiated: April 4, 2016 #D-1052-2016
Product Description
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
Reason for Recall
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 59,520 Bottles
- Distribution
- Nationwide and Puerto Rico
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 59,520 Bottles.
Why was this product recalled? ▼
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 6, 2016. Severity: Low. Recall number: D-1052-2016.
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