Home / Recalls / Mylan Laboratories Limited, (Nashik FDF) / D-0327-2019

D-0327-2019 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
129,754 HDPE bottles

Product Description

Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-5815-77.

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: 3063783 3063784 3063785 3064092 3064093 3064094 3070349 3070350 3070351 3070352 3070353 3070354 3079030 3079031 3079032 3079033 3080011 3080224 3081498 3081500 3087126 3088476

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-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-0328-2019 Class II — Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle ( (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)