Lupin Recalls Cefdinir Oral Suspension Due to Metal Piece Complaint
Lupin Pharmaceuticals is recalling 18,408 bottles of Cefdinir for Oral Suspension after a complaint of a metal piece found in the product.
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: The recall involves a risk-of-harm product (foreign object in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 18,408 bottles of Cefdinir for Oral Suspension USP, 250mg/5mL, Powder for oral suspension, 60 mL bottle. The product is identified by Lot # F802335 and has an expiration date of November 2020. It is distributed nationwide in the USA.
The recall was initiated following a complaint identifying a metal piece in the product bottle prior to reconstitution. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in India.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- 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 # F802335
- exp. date November 2020
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
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Similar recalls
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