Drug recall D-0529-2020

Class II Ongoing reported Dec 4, 2019

Product

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

Reason for recall

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Lots and codes

UI1519001-A UI1519002-A UI1519003-A UI1519004-A

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
19320 bottles
Distribution
nationwide
Type
Voluntary: Firm initiated
Recall initiated
November 6, 2019