Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Reported: December 19, 2018 Initiated: December 4, 2018 #D-0331-2019
Product Description
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), 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.
Details
- Recalling Firm
- Mylan Laboratories Limited, (Nashik FDF)
- Units Affected
- 19,352 HDPE bottles
- Distribution
- Product was distributed throughout the United States to several major distributors, including Puerto Rico.
- Location
- Sinnar, Nashik District, N/A
Frequently Asked Questions
What product was recalled? ▼
Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.. Recalled by Mylan Laboratories Limited, (Nashik FDF). Units affected: 19,352 HDPE bottles.
Why was this product recalled? ▼
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 19, 2018. Severity: Moderate. Recall number: D-0331-2019.
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