Home / Recalls / Novitium Pharma LLC / D-0312-2020

D-0312-2020 Class II Terminated

Recalled by Novitium Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
November 20, 2019
Initiation Date
October 25, 2019
Termination Date
March 17, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12312 bottles

Product Description

Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution Pattern

Nationwide

Code Information

all lots within expiry.

Other recalls by Novitium Pharma LLC

  • D-0443-2024 Class III — Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactu (March 25, 2024)
  • D-0389-2024 Class III — Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufacture (March 4, 2024)
  • D-0311-2020 Class II — Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: (October 25, 2019)
  • D-0310-2020 Class II — Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: (October 25, 2019)
  • D-0313-2020 Class II — Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: (October 25, 2019)