Sun Pharma Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Matter
Sun Pharmaceutical Industries is recalling one lot of Sulfamethoxazole and Trimethoprim tablets because polyethylene was detected in two tablets.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The presence of foreign matter (polyethylene) in a small number of tablets fits this moderate risk profile without reported injuries.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling one lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, 500-count bottles. The recall is due to the detection of a foreign substance identified as polyethylene in two tablets.
The affected product is manufactured by Frontida BioPharm, Inc. and distributed by Sun Pharmaceutical Industries, Inc. The specific lot number is 6848501 with an expiration date of 04/2020. A total of 1,908 bottles were distributed nationwide in the USA.
Consumers should check their medication for this specific lot number and expiration date. If they have this product, they should stop using it and contact their healthcare provider or pharmacist for guidance on replacement or disposal.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 6848501
- EXP 04/2020
UPCs (2)
- 0353489146012
- 0353489145015
Distribution
Distributed nationwide across the United States.
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