FDA Drug recall D-1046-2019
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE…
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE… by Avkare, citing CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1046-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-05 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
Reason
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Identifiers
| code_info | Lot: 19326 Exp. 03/31/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Avkare
- Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com…
FDA Drug · Class II · 2026-03-04 · Avkare - Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478
FDA Drug · Class II · 2026-01-14 · Avkare - Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister c…
FDA Drug · Class II · 2025-10-15 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 3847…
FDA Drug · Class II · 2025-09-17 · Avkare - chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 384…
FDA Drug · Class II · 2025-09-17 · Avkare
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1046-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.