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 indicates the product is not likely to cause adverse health consequences. The hazard is a cosmetic/foreign object issue (dead ant) with no reported illnesses or injuries.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling specific lots of Cefdinir for Oral Suspension USP, 125 mg/5mL. The recall was initiated because a foreign substance, identified as a dead ant, was present in the product.
The affected product is a prescription-only oral suspension manufactured for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in India. The recall covers 4,074 bottles of the 60 mL size (NDC 68180-722-20, Lot F900153) and 30,300 bottles of the 100 mL size (NDC 68180-722-10, Lots F802327, F802328, and F802329). All affected bottles have an expiration date of 11/20.
The product was distributed to major distributors and wholesalers throughout the United States. Consumers and healthcare providers should check their inventory for these specific NDCs, lot numbers, and expiration dates. If found, the product should be returned to the distributor or wholesaler from which it was purchased.
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 (5)
- Lot #: a) F900153
- Exp 11/20
- b) F802327
- F802328
- F802329
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.
See all 3 products in this recall →Related recalls
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