Home / Recalls / Avet Pharmaceuticals, Inc. / D-1104-2020

D-1104-2020 Class II Terminated

Recalled by Avet Pharmaceuticals, Inc. — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
April 15, 2020
Initiation Date
March 26, 2020
Termination Date
March 8, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 12,168; b) 17,196; c) 3,890

Product Description

Losartan Potassium Tablets USP 100 mg, supplied in a) 30 count (NDC 23155-646-03, b) 90 count (NDC 23155-646-09) and 1000 count (NDC 23155-646-10) bottles, Rx only, Manufactured by: Vivimed Life Sciences Private Limited, Tamil Nadu, India Manufactured for: Heritage Pharmaceutical Inc., East Brunswick, NJ 08816

Reason for Recall

CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level

Distribution Pattern

Nationwide

Code Information

a) CL018022B, exp Apr 2020 b) CL018010A Mar 2020; CL018017B, CL018018A exp Apr 2020 c) CL018011A, CL018012A exp Mar 2020; CL018013A, CL018015A, CL018016A, CL018017A, exp Apr 2020

Other recalls by Avet Pharmaceuticals, Inc.

  • D-1103-2020 Class II — Losartan Potassium Tablets USP 50 mg, a) 30 count (NDC 23155-645-03), b) 90 coun (March 26, 2020)
  • D-1255-2020 Class I — Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured (March 23, 2020)
  • D-1254-2020 Class I — Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactured (March 23, 2020)