D-1269-2019 Class II Ongoing
FDA drug recall D-1269-2019 was initiated by Torrent Pharma Inc. on April 18, 2019 and is designated Class II. Reason for recall: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level. The recall status is ongoing. Affected quantity: 239,016 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 239,016 bottles
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets, USP, 100mg/25mg, a) 30-count (NDC: 13668-118-30) b) 90-count (NDC: 13668-118-90), c) 1000-count (NDC: 13668-118-10), per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Reason for Recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Count, lots, expiry: [30-count bottle] Lot BEF6D054, exp 8/31/2020; [90-count bottle] Lot BP04C092, exp 10/31/2019; Lots BP04D012, BP04D013, exp 12/31/2019; Lots BEF6D012, BEF6D013, exp 3/31/2020; Lots BEF6D060, BEF6D061, BEF6D063, exp 9/30/2020; Lots BEF6D076, BEF6D077, BEF6D078, BEF6D079, exp 10/31/2020; Lots BEF6D100, BEF6D101, BEF6D102, exp 11/30/2020; Lots BEF6E001, BEF6E002, BEF6E003, BEF6E004, BEF6E008, BEF6E009, BEF6E010, BEF6E011, BEF6E012, exp 12/31/2020