Sanofi Recalls Subpotent Rifadin Capsules Due to Low Fill
Sanofi-Synthelabo is recalling 998 bottles of Rifadin (rifampin) capsules because some capsules contained less medication than labeled.
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 source text explicitly identifies the agency classification as Class II. Per the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), as they pose a temporary or medically reversible health risk.
Plain-English summary
Sanofi-Synthelabo is recalling 998 bottles of Rifadin (rifampin) capsules, USP, 150 mg, 100-count. The affected product is Lot # 3099036, with an expiration date of 03/2014. The product was distributed in Canada.
The recall was initiated after the manufacturer reviewed retain samples and observed low fill in some capsules. This issue was related to a problem detected with the encapsulating equipment. The agency has classified this as a Class II recall.
Consumers who have this specific lot of Rifadin capsules should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- Rifadin (rifampin) capsules, USP, 150 mg, 100-count capsules per bottle, Manufactured by: Fabrique par Sanofi-Aventis Canada Inc., Laval, Quebec, Canada H7L4A8, DIN # 02091887
- Manufacturer
- Sanofi-Synthelabo
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 998
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 # 3099036
- Exp 03/2014
Distribution
Distribution scope not specified by the agency.
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