Citron Pharma Recalls Penicillin V Potassium Tablets Due to Foreign Tablet Presence
Citron Pharma LLC is recalling 420 bottles of Penicillin V Potassium 500 mg tablets because Amoxicillin 500 mg tablets were found in the bottles.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of, or exposure to, the product is not likely to cause adverse health consequences. The hazard involves a foreign tablet (Amoxicillin) in a Penicillin V bottle, which is a labeling/packaging error rather than a high-risk pathogen or structural defect.
Plain-English summary
Citron Pharma LLC is recalling 420 bottles of Penicillin V Potassium Tablets, USP 500 mg (800,000 units), 1000 count bottles. The recall is due to the presence of foreign tablets, specifically Amoxicillin 500 mg, found in bottles of Penicillin V Potassium 500 mg.
The affected product is identified by Batch Number PE5015069-A with an expiration date of 11/2018. The product was distributed nationwide. The NDC for the recalled product is 57237-041-99.
Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase. Patients should consult their healthcare provider for appropriate treatment or alternative medication.
The recalled product
- Product
- PENICILLIN V POTASSIUM (PENICILLIN V POTASSIUM)
- Brand
- PENICILLIN V POTASSIUM
- Manufacturer
- Citron Pharma Llc
- Category
- Drug — Prescription Drug
- Affected units
- 420
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)
- Batch Numbers: PE5015069-A
- exp 11/2018
UPCs (2)
- 0357237041017
- 0357237040010
Distribution
Distributed nationwide across the United States.
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