July 2021 FDA Recall Drug by Aurobindo Pharma Usa Inc.
D-0719-2021 - Presence of Foreign Substance- Potential of metal contamination.
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on July 7, 2021 for the product Drug. The FDA reported the reason for recall as presence of foreign substance- potential of metal contamination.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0719-2021
Presence of Foreign Substance- Potential of metal contamination.
07-07-2021
08-18-2021
3800 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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
10-18-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
Batch or Lot Expiration Information
Batch# Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
