Sanofi Recalls Subpotent Rifadin Rifampin Capsules Due to Low Fill Volume
Sanofi US is recalling 2,462 bottles of Rifadin (Rifampin) 150 mg capsules because some capsules contain low fill volume, resulting in subpotent drug.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury/property-damage reports or hospitalization reports are Severe. While no specific injuries are reported in the text, the classification and the nature of a subpotent drug (risk of treatment failure) align with the Severe criteria for Class II recalls involving significant health risks.
Plain-English summary
Sanofi US is recalling 2,462 bottles of Rifadin (Rifampin) 150 mg capsules, packaged in 30-count bottles. The recall is due to low fill volume in some of the capsules, which results in a subpotent drug.
The affected product is identified by Lot # 3097657 and an expiration date of 3/15. The NDC number is 0068-0510-30. The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for a replacement or further instructions.
The recalled product
- Product
- Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30
- Manufacturer
- Sanofi US
- Category
- Drug — Antibiotic
- Affected units
- 2,462
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)
- Lot # 3097657
- Exp 3/15
Distribution
Distributed nationwide across the United States.
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