Drug 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
D-0719-2021
Product summary
- Event
- Event 88227
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3800 bottles
- Official record key
drug-enforcement:D-0719-2021
Official wording
Reason: Presence of Foreign Substance- Potential of metal contamination.
Code information: Batch SP1D19082AA3 & Batch SP1D19085AA3; Exp 08/2022
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance