Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Auro
Summary
The FDA issued a Class II for Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 by Aurobindo Pharma USA Inc.. Reason: Presence of Foreign Substance- Potential of metal contamination..
Details
Source
Drug Recall
External ID
D-0719-2021
Action Date
2021-08-18
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Quantity Affected: 3800 bottles
Reason for Recall
Presence of Foreign Substance- Potential of metal contamination.
Distribution
Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-07
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurobindo Pharma USA Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc. have FDA actions?
Aurobindo Pharma USA Inc. has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0719-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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