D-1535-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 2, 2020
- Initiation Date
- August 10, 2020
- Termination Date
- June 28, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5748 bottles
Product Description
Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC: 65862-420-05.
Reason for Recall
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Distribution Pattern
Nationwide in the U.S.
Code Information
Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.