Mylan Laboratories Limited, (Nashik FDF) Recall: Valsartan and Hydrochlorothiazide Tablets
Mylan Laboratories Limited, (Nashik FDF) Recall: Valsartan and Hydrochlorothiazide Tablets is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Mylan Laboratories Limited, (Nashik FDF); Product: Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-7
| Recalling firm | Mylan Laboratories Limited, (Nashik FDF) |
|---|---|
| Product | Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottles (NDC 0378-6322-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. |
| Reason for recall | GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Product was distributed throughout the United States to several major distributors, including Puerto Rico. |
| Recall initiated | 20181204 |
| Recall number | D-0329-2019 |
| Category | drug |
| State | N/A |
| Country | India |
$29/mo
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