Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns
Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.
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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall with a significant hazard such as a superpotent drug (which implies a risk of overdose or toxicity) falls under the 'Severe' category (Score 4), as it is not a Class I (Critical) but represents a significant potential for harm.
Plain-English summary
Lupin Pharmaceuticals Inc. is voluntarily recalling Cefprozil for Oral Suspension USP, 250mg/5mL. The recall is initiated because the product is a superpotent drug, meaning it may contain more active ingredient than intended. The affected product is a prescription-only oral suspension manufactured by Lupin Limited in India for Lupin Pharmaceuticals Inc. in Baltimore, Maryland.
The recall includes three specific lot numbers: F801122, F801123, and F801124, all with expiration dates of June 2021. The affected packages are 50 mL, 75 mL, and 100 mL bottles (when mixed) with NDC codes 68180-402-01, 68180-402-02, and 68180-402-03, respectively. The total quantity recalled is 6,816 bottles of the 50 mL size, 3,960 bottles of the 75 mL size, and 7,038 bottles of the 100 mL size.
These products were distributed nationwide in the United States and Puerto Rico. The FDA has classified this recall as Class II, which indicates a situation that could temporarily cause serious adverse health consequences or where the probability of serious adverse health consequences is remote. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.
The recalled product
- Product
- CEFPROZIL (CEFPROZIL)
- Brand
- CEFPROZIL
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Antibiotic
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 Numbers: a) F801122
- exp. date June 2021
- b) F801123
- c) F801124
UPCs (2)
- 0368180401032
- 0368180402039
Distribution
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