Why it was recalled
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
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
Lot numbers, UPCs & expiration codes
Lot #: a) H303459, b) H303460, Exp 09/2016
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1052-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 4, 2016
- FDA report date
- Jul 6, 2016
- Quantity
- 59,520 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1052-2016, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 73848
- Address
- 111 S Calvert St Fl 21ST
- Code information
- Lot #: a) H303459, b) H303460, Exp 09/2016
- Postal code
- 21202-6174
- Report date
- Jul 6, 2016
- Product type
- Drugs
- Recall number
- D-1052-2016
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 59,520 Bottles
- Termination date
- Jun 1, 2017
- Reason for recall
- CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Apr 4, 2016
- Initial firm notification
- Center classification date
- Jun 24, 2016