Drug recall D-0649-2020

Class II Terminated reported Jan 15, 2020

Product

Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.

Reason for recall

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

Lots and codes

Batch # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021

Recall details

Recalling firm
Appco Pharma LLC, Piscataway, NJ
Quantity
624 bottes
Distribution
Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Type
Voluntary: Firm initiated
Recall initiated
January 7, 2020
Terminated
April 24, 2020