Furosemide tablets recalled over the presence of a foreign substance
Graviti Pharmaceuticals is recalling 4,212 bottles of Furosemide Tablets, USP 40 mg over the presence of a foreign substance.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a foreign substance in an oral tablet is a physical contamination hazard, and no injuries are reported.
Plain-English summary
Furosemide Tablets, USP 40 mg, in 1,000-tablet bottles, Rx only, manufactured by Graviti Pharmaceuticals Pvt. Ltd. of Telangana, India for Rising Pharmaceuticals Inc. of East Brunswick, New Jersey, under NDC 64980-563-10, are being recalled.
The reason given in the enforcement record is the presence of a foreign substance.
The record lists 4,212 bottles from lot FUB125042G, expiry 05/13/2027. Distribution was nationwide in the US. The FDA has classified the action as Class II.
The record does not identify the substance and reports no injuries. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- FUROSEMIDE (FUROSEMIDE)
- Brand
- FUROSEMIDE
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Category
- Drug — Diuretic
- Affected units
- 4,212
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# FUB125042G
- Exp. 05/13/2027
UPCs (1)
- 0364980564014
Distribution
Distributed nationwide across the United States.
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