January 2021 FDA Recall Drug by Aurobindo Pharma Usa Inc.
D-0290-2021 - Presence of foreign tablets/capsules
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on January 20, 2021 for the product Drug. The FDA reported the reason for recall as presence of foreign tablets/capsules. The product was distributed in TX, CA, GA, PA and the recall is currently terminated.
Recall Number: D-0290-2021
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
01-20-2021
03-10-2021
1296 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
TX, CA, GA, PA
10-12-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : P2000467, Exp 7/2022
