Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product description
Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Lot numbers, UPCs & expiration codes
H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H100935, exp. date Mar-23 H001470,, exp. date Nov-22 H002842, exp. date Jan-23 H101081, exp. date Mar-23 H001484, exp. date Dec-22 H002843, exp. date Jan-23 H101148, exp. date Mar-23 H001485, exp. date Dec-22 H002995, exp. date Jan-23 H101639, exp. date Mar-23 H001708, exp. date Dec-22 H003199, exp. date Feb-23 H101480, exp. date Mar-23 H002314, exp. date Dec-22 H003200, exp. date Feb-23 H101822, exp. date Mar-23 H001709, exp. date Dec-22 H100028, exp. date Feb-23 H101481, exp. date Mar-23 H002001, exp. date Dec-22 H100712, exp. date Feb-23 H102288, exp. date Mar-23 H001991, exp. date Dec-22 H100221, exp. date Feb-23 H002000, exp. date Dec-22 H100222, exp. dateFeb-23 H903582, exp. date Oct-22 H001707, exp. dateDec-22 H100220, exp. date Feb-23 H000556,, exp. date Nov-22 H003045, exp. date Dec-22 H100901, exp. date Mar-23 H000557, exp. date Nov-22 H002391, exp. date Dec-22 H101078, exp. date Mar-23 H001061, exp. date Nov-22 H002312, exp. date Jan-23 H101479, exp. date Mar-23 H001062, exp. date Nov-22 H002517, exp. date Jan-23 H101496, exp. date Mar-23 H001431, exp. date Nov-22 H002841, exp. date Jan-23 H101821, exp. date Mar-23 H002341, exp. date Nov-22 H003044, exp. date Feb-23 H102286, exp. date Mar-23 H001706, exp. date Dec-22 H003198, exp. date Feb-23 H102287, exp. date Mar-23
Where it was sold
Product was distributed nationwide
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-0840-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 31, 2022
- FDA report date
- May 11, 2022
- Quantity
- 1,247,067 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0840-2022, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 89916
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- H903573, exp. date Oct-22 H002311, exp. date Dec-22 H100713, exp. date Mar-23 H001060, exp. date Nov-22 H002620, exp. date Jan-23 H100714, exp. date Mar-23 H001456, exp. date Nov-22 H002313, exp. date Jan-23 H100934, exp. date Mar-23 H001457, exp. date Nov-22 H002490, exp. date Jan-23 H100935, exp. date Mar-23 H001470,, exp. date Nov-22 H002842, exp. date Jan-23 H101081, exp. date Mar-23 H001484, exp. date Dec-22 H002843, exp. date Jan-23 H101148, exp. date Mar-23 H001485, exp. date Dec-22 H002995, exp. date Jan-23 H101639, exp. date Mar-23 H001708, exp. date Dec-22 H003199, exp. date Feb-23 H101480, exp. date Mar-23 H002314, exp. date Dec-22 H003200, exp. date Feb-23 H101822, exp. date Mar-23 H001709, exp. date Dec-22 H100028, exp. date Feb-23 H101481, exp. date Mar-23 H002001, exp. date Dec-22 H100712, exp. date Feb-23 H102288, exp. date Mar-23 H001991, exp. date Dec-22 H100221, exp. date Feb-23 H002000, exp. date Dec-22 H100222, exp. dateFeb-23 H903582, exp. date Oct-22 H001707, exp. dateDec-22 H100220, exp. date Feb-23 H000556,, exp. date Nov-22 H003045, exp. date Dec-22 H100901, exp. date Mar-23 H000557, exp. date Nov-22 H002391, exp. date Dec-22 H101078, exp. date Mar-23 H001061, exp. date Nov-22 H002312, exp. date Jan-23 H101479, exp. date Mar-23 H001062, exp. date Nov-22 H002517, exp. date Jan-23 H101496, exp. date Mar-23 H001431, exp. date Nov-22 H002841, exp. date Jan-23 H101821, exp. date Mar-23 H002341, exp. date Nov-22 H003044, exp. date Feb-23 H102286, exp. date Mar-23 H001706, exp. date Dec-22 H003198, exp. date Feb-23 H102287, exp. date Mar-23
- Postal code
- 21202-6174
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0840-2022
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 1,247,067 bottles
- Termination date
- May 22, 2023
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Mar 31, 2022
- Initial firm notification
- Letter
- Center classification date
- May 3, 2022