Lupin Recalls Cefdinir Oral Suspension Due to Out-of-Specification Assay Results
Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to out-of-specification assay results in retention samples.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe severity score (4) according to the rubric, as it involves a potential health risk that may cause temporary or medically reversible harm.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Cefdinir for Oral Suspension USP, 250 mg/5mL, packaged in 60 mL bottles. The recall involves 35,928 bottles distributed nationwide in the United States. The specific lots affected are # F802189 (Exp 10/2020) and # F900240 (Exp 1/2021).
The recall was initiated because an out-of-specification (OOS) result was observed in an assay test of retention samples. This indicates that the drug product may not meet the required potency standards.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in Mandideep, India.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 35,928
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 (4)
- Lot # F802189
- Exp 10/2020
- F900240
- Exp 1/2021
UPCs (1)
- 0368180723042
Distribution
Distributed nationwide across the United States.
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