Home / Recalls / Heritage Pharmaceuticals, Inc. / D-1287-2019

D-1287-2019 Class II Terminated

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

Recall Details

Product Type
Drugs
Report Date
May 29, 2019
Initiation Date
May 3, 2019
Termination Date
November 16, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3012 bottles

Product Description

Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC 23155-645-10

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 at the manufacturer

Distribution Pattern

Nationwide

Code Information

Lot CLO17007A Lot CLO17008A Lot CLO17009A ; Exp 11/2019

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  • D-0107-2026 Class II — Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578 (October 6, 2025)
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  • D-0072-2023 Class II — Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: (November 23, 2022)
  • D-0367-2021 Class III — Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharm (April 21, 2021)
  • D-0108-2021 Class III — Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distri (October 23, 2020)
  • D-1398-2019 Class I — AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mf (May 21, 2019)