Drug recall D-0310-2020

Class II Terminated reported Nov 20, 2019

Product

Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20

Reason for recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Lots and codes

all lots within expiry.

Recall details

Recalling firm
Novitium Pharma LLC, East Windsor, NJ
Quantity
19560 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
October 25, 2019
Terminated
March 17, 2021