Why it was recalled
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Product description
Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
Lot numbers, UPCs & expiration codes
a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
Where it was sold
AL, GA, FL, LA
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-0971-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 5, 2022
- FDA report date
- Jun 8, 2022
- Quantity
- 81 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0971-2022, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 90161
- Address
- 94 Worldwide Dr
- Code information
- a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22
- Postal code
- 30534-6828
- Report date
- Jun 8, 2022
- Product type
- Drugs
- Recall number
- D-0971-2022
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 81 bottles
- Termination date
- Oct 5, 2023
- Reason for recall
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90
- Distribution pattern
- AL, GA, FL, LA
- Recall initiation date
- May 5, 2022
- Initial firm notification
- Letter
- Center classification date
- May 27, 2022