Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Reported: March 27, 2019 Initiated: March 5, 2019 #D-1045-2019
Product Description
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15
Reason for Recall
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Details
- Recalling Firm
- AVKARE Inc.
- Units Affected
- N/A
- Distribution
- Nationwide.
- Location
- Pulaski, TN
Frequently Asked Questions
What product was recalled? ▼
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-513-15. Recalled by AVKARE Inc.. Units affected: N/A.
Why was this product recalled? ▼
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 27, 2019. Severity: Moderate. Recall number: D-1045-2019.
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