Drug product
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.
D-1535-2020
Product summary
- Event
- Event 86190
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5748 bottles
- Official record key
drug-enforcement:D-1535-2020
Official wording
Reason: Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
Code information: Lot #s: STSD19109-A, Exp. 05/31/2022; SP1D19083AA3, SP1D19084AA3, Exp. 08/31/2022.
Distribution pattern: Nationwide in the U.S.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance