Mylan Recalls Rifampin Injection Vials Due to Impurity Concerns
Mylan Laboratories is recalling 19,165 vials of Rifampin for Injection due to elevated unknown impurities that may reduce product effectiveness.
What this means for you
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 II. The hazard involves reduced effectiveness due to impurities rather than direct toxicity or reported injuries, fitting the criteria for moderate severity.
Plain-English summary
Mylan Laboratories Limited (Sterile Products Division) is recalling 19,165 vials of Rifampin for Injection, USP, 600 mg/vial. The product is a prescription-only intravenous antibiotic manufactured for Mylan Institutional LLC. The recall covers Lot 7008334 (Exp April 2020) and Lot 7008417 (Exp Oct 2020), with NDC 67457-445-60.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, the vials exhibited discoloration due to elevated unknown impurity results. This condition could decrease the effectiveness of the product.
The affected vials were distributed nationwide in the USA. Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- RIFAMPIN (RIFAMPIN)
- Brand
- RIFAMPIN
- Category
- Drug — Antibiotic
- Affected units
- 19,165
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: 7008334
- Exp April 2020
- 7008417
- Exp Oct 2020
Distribution
Distributed nationwide across the United States.
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