Home / Recalls / Mylan Laboratories Limited, (Nashik FDF) / D-0326-2019

D-0326-2019 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
232,180 HDPE bottles

Product Description

Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-5814-77.

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: 3069019, 3069020, 3069021, 3069022, 3071354, 3071355, 3071357 3079023 3079027 3079028 3079029 3079996 3079997 3079998 3083635 3086715 3086716 3086717 3088623

Other recalls by Mylan Laboratories Limited, (Nashik FDF)

  • 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-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)