Lupin Recalls Cefdinir Oral Suspension Due to Foreign Substance
Lupin Pharmaceuticals is recalling specific lots of Cefdinir for Oral Suspension because a dead ant was found in the product.
What this means for you
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. The hazard is a foreign substance (dead ant) with no reported illnesses or injuries.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling 30,516 bottles of Cefdinir for Oral Suspension USP, 250 mg/5mL, 100 mL bottles. The recall was initiated due to the presence of a foreign substance, identified as a dead ant, in the product.
The affected product is prescription-only and was distributed to major distributors and wholesalers throughout the United States. The specific lots involved are F802345, F802346, and F802347, all with an expiration date of 11/20. The product is manufactured by Lupin Limited in India for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland.
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the distributor or wholesaler from which it was purchased. No specific instructions for individual patients are provided in the source text, but patients should consult their healthcare provider if they have concerns about the medication.
The recalled product
- Product
- CEFDINIR (CEFDINIR)
- Brand
- CEFDINIR
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 30,516
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 #: F802345
- F802346
- F802347
- Exp 11/20
UPCs (1)
- 0368180723042
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Lupin Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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