D-0290-2021 Class II Terminated

Recalled by Aurobindo Pharma USA Inc. — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
March 10, 2021
Initiation Date
January 20, 2021
Termination Date
October 12, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1296 bottles

Product Description

Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India, NDC 65862-860-99

Reason for Recall

Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.

Distribution Pattern

TX, CA, GA, PA

Code Information

Lot #: P2000467, Exp 7/2022