Home / Recalls / Mylan Laboratories Limited, (Nashik FDF) / D-0328-2019

D-0328-2019 Class II Ongoing

Recalled by Mylan Laboratories Limited, (Nashik FDF) — Sinnar, Nashik District, N/A

Recall Details

Product Type
Drugs
Report Date
December 19, 2018
Initiation Date
December 4, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32,696 HDPE bottles

Product Description

Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), 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.

Distribution Pattern

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

Code Information

Lot numbers: 3084363, 3084364, 3093800, 3084363, 3093800

Other recalls by Mylan Laboratories Limited, (Nashik FDF)

  • D-0326-2019 Class II — Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufac (December 4, 2018)
  • D-0327-2019 Class II — Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufac (December 4, 2018)
  • D-0324-2019 Class II — Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufact (December 4, 2018)
  • D-0325-2019 Class II — Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufact (December 4, 2018)
  • D-0332-2019 Class II — Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (N (December 4, 2018)
  • D-0330-2019 Class II — Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (N (December 4, 2018)
  • D-0321-2019 Class II — Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made (December 4, 2018)
  • D-0322-2019 Class II — Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made (December 4, 2018)
  • D-0329-2019 Class II — Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (December 4, 2018)
  • D-0320-2019 Class II — Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made (December 4, 2018)