D-0719-2021 Class II Terminated
FDA drug recall D-0719-2021 was initiated by Aurobindo Pharma USA Inc. on July 7, 2021 and is designated Class II. Reason for recall: Presence of Foreign Substance- Potential of metal contamination. The recall status is terminated (terminated October 18, 2023). Affected quantity: 3800 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 18, 2021
- Initiation Date
- July 7, 2021
- Termination Date
- October 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3800 bottles
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
Reason for Recall
Presence of Foreign Substance- Potential of metal contamination.
Distribution Pattern
Nationwide
Code Information
Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022