Telmisartan Tablets Recalled Due to Presence of Silicone Foreign Matter
Torrent Pharmaceuticals is recalling Telmisartan 80 mg tablets because a product complaint identified silicone foreign matter within the tablets.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the source text does not report any injuries or illnesses.
Plain-English summary
Torrent Pharmaceuticals Limited is recalling 20,952 cartons of Telmisartan Tablets, USP, 80 mg. The recall was initiated after a product complaint identified the presence of foreign matter, specifically silicone, within the tablets.
The affected product is identified by Lot number BBV8B002R and has an expiration date of 12/16. The product was distributed nationwide. The recall is classified as Class III by the FDA.
Consumers and healthcare providers should stop using the affected lot of Telmisartan tablets and contact their healthcare provider for guidance on alternative treatment options. The recalled product should be returned to the pharmacy or point of purchase.
The recalled product
- Product
- Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3…
- Manufacturer
- Torrent Pharmaceuticals Limited
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 20,952
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#: BBV8B002R
- Exp 12/16
Distribution
Distributed nationwide across the United States.
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