Aurobindo Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Metal Wire
Aurobindo Pharma USA Inc. is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets because of reports of metal wire in the 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of foreign metal wire in oral tablets poses a risk of injury, meeting the criteria for a Severe rating.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg Double Strength, 500 Tablets per bottle. The recall involves 5,748 bottles distributed nationwide in the U.S. The affected lots are STSD19109-A with an expiration date of 05/31/2022, and SP1D19083AA3 and SP1D19084AA3 with an expiration date of 08/31/2022. The product is identified by NDC 65862-420-05.
The recall was initiated because the firm received product complaints regarding the presence of metal wire in the tablets. This is an FDA Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed this medication.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,748
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 (5)
- Lot #s: STSD19109-A
- Exp. 05/31/2022
- SP1D19083AA3
- SP1D19084AA3
- Exp. 08/31/2022.
Distribution
Distributed nationwide across the United States.
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